A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly s.c. Administered GL0034 in Adults with Type 2 Diabetes Mellitus Inadequately controlled on Metformin Or Diet and Exercise - SP-GL0034-02

Start Date06 Sep 2024

Sponsor / Collaborator

Sun Pharmaceutical Industries Ltd.

ACTRN12624000322538 / RecruitingPhase 1/2

A Phase 1b/2a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy, Safety, Tolerability and the Pharmacokinetics of GL0034 (Utreglutide) in the Treatment of Non-alcoholic Fatty Liver Disease

Start Date28 Mar 2024

Sponsor / Collaborator-

100 Clinical Results associated with Utreglutide

100 Translational Medicine associated with Utreglutide

100 Patents (Medical) associated with Utreglutide

Literatures (Medical) associated with Utreglutide

01 Nov 2022·Diabetes, obesity & metabolism

In vivo and in vitro characterization of GL0034, a novel long‐acting glucagon‐like peptide‐1 receptor agonist

Article

Author: Thorens, Bernard ; Akalestou, Elina ; Burade, Vinod ; Ramchunder, Zenouska ; Jones, Ben ; Rutter, Guy A. ; Leclerc, Isabelle ; Thennati, Rajamannar ; Tomas, Alejandra ; Piemonti, Lorenzo ; Manchanda, Yusman ; Carrat, Gaëlle ; Vilsboll, Tina ; Nguyen‐Tu, Marie‐Sophie ; Marchetti, Piero

Abstract:

Aims:

To describe the in vitro characteristics and antidiabetic in vivo efficacy of the novel glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) GL0034.

Materials and Methods:

Glucagon‐like peptide‐1 receptor (GLP‐1R) kinetic binding parameters, cyclic adenosine monophosphate (cAMP) signalling, endocytosis and recycling were measured using HEK293 and INS‐1832/3 cells expressing human GLP‐1R. Insulin secretion was measured in vitro using INS‐1832/3 cells, mouse islets and human islets. Chronic administration studies to evaluate weight loss and glycaemic effects were performed in db/db and diet‐induced obese mice.

Results:

Compared to the leading GLP‐1RA semaglutide, GL0034 showed increased binding affinity and potency‐driven bias in favour of cAMP over GLP‐1R endocytosis and β‐arrestin‐2 recruitment. Insulin secretory responses were similar for both ligands. GL0034 (6 nmol/kg) led to at least as much weight loss and lowering of blood glucose as did semaglutide at a higher dose (14 nmol/kg).

Conclusions:

GL0034 is a G protein‐biased agonist that shows powerful antidiabetic effects in mice, and may serve as a promising new GLP‐1RA for obese patients with type 2 diabetes.

01 Jan 2019·Applied microbiology and biotechnologyQ3 · ENGINEERING & TECHNOLOGY

Stimulatory effects of novel glucosylated lactose derivatives GL34 on growth of selected gut bacteria

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Boger, Markus C L ; Dijkhuizen, Lubbert ; Pham, Hien T T ; van Leeuwen, Sander S

Previously we structurally characterized five glucosylated lactose derivatives (F1-F5) with a degree of polymerization (DP) of 3-4 (GL34), products of Lactobacillus reuteri glucansucrases, with lactose and sucrose as substrates. Here, we show that these GL34 compounds are largely resistant to the hydrolytic activities of common carbohydrate-degrading enzymes. Also, the ability of single strains of gut bacteria, bifidobacteria, lactobacilli, and commensal bacteria, to ferment the GL34 compounds was studied. Bifidobacteria clearly grew better on the GL34 mixture than lactobacilli and commensal bacteria. Lactobacilli and the commensal bacteria Escherichia coli Nissle and Bacteroides thetaiotaomicron only degraded the F2 compound α-D-Glcp-(1 → 2)-[β-D-Galp-(1 → 4)-]D-Glcp, constituting around 30% w/w of GL34. Bifidobacteria digested more than one compound from the GL34 mixture, varying with the specific strain tested. Bifidobacterium adolescentis was most effective, completely degrading four of the five GL34 compounds, leaving only one minor constituent. GL34 thus represents a novel oligosaccharide mixture with (potential) synbiotic properties towards B. adolescentis, synthesized from cheap and abundantly available lactose and sucrose.

01 Dec 2018·Carbohydrate researchQ4 · CHEMISTRY

Structural characterization of glucosylated GOS derivatives synthesized by the Lactobacillus reuteri GtfA and Gtf180 glucansucrase enzymes

Q4 · CHEMISTRY

Article

Author: Dijkhuizen, Lubbert ; van Leeuwen, Sander S ; Pham, HienT T

β-Galacto-oligosaccharides (GOS) are used commercially in infant nutrition, aiming to functionally replace human milk oligosaccharides (hMOS). Glucansucrases Gtf180-ΔN and GtfA-ΔN of Lactobacillus reuteri strains convert sucrose into α-glucans with (α1→6)/(α1→3) and (α1→4)/(α1→6) glucosidic linkages, respectively. Previously we reported that both glucansucrases glucosylate lactose, producing a minimum of 5 compounds (degree of polymerization 3-4) (GL34 mixture) with (α1→2/3/4) linkages. This GL34 mixture exhibited growth stimulatory effects on various probiotic bacteria. Aiming to obtain additional compounds mimicking hMOS in structure and function, we here studied glucosylation of 3 commercially available galactosyl-lactose GOS compounds. Both Gtf180-ΔN and GtfA-ΔN were unable to use 3'-galactosyl-lactose (β3'-GL), but used sucrose to add a single glucose moiety to 4'-galactosyl-lactose (β4'-GL) and 6'-galactosyl-lactose (β6'-GL). β6'-GL was elongated at its reducing glucosyl unit with an (α1→2)-linked moiety and at its non-reducing end with an (α1→4) linked moiety; β4'-GL was only elongated at its reducing end with an (α1→2) linked moiety. Glucansucrases Gtf180-ΔN and GtfA-ΔN thus can be used to produce galactosyl-lactose-derived oligosaccharides containing (α1→2) and (α→4) glucosidic linkages, potentially with valuable bioactive (prebiotic) properties.

News (Medical) associated with Utreglutide

22 Jun 2024

·www.prnewswire.com

Sun Pharma's GL0034 (Utreglutide) Demonstrates Significant Weight Loss, Gluco-metabolic and Lipid Lowering Efficacy in Individuals with Obesity in Oral Presentation at the American Diabetes Association 84th Scientific Sessions

GL0034 administered once-weekly confirmed clinically meaningful weight loss and improved gluco-metabolic parameters over a 4-week treatment period in individuals with obesity, even in the lowest dosing regimen. GL0034 demonstrated gluco-metabolic activity and reductions in lipid levels, including triglycerides, total cholesterol, and non-HDL cholesterol, suggesting novel and beneficial effects on lipid metabolism. GL0034 exhibited a favorable tolerability profile, with gastrointestinal (GI) adverse events consistent with those typically observed in the incretin class. These findings highlight GL0034's potential as a therapeutic option for individuals with obesity, providing not only weight loss but also improvements in key cardiometabolic biomarkers. MUMBAI, India and NEW YORK, June 22, 2024 /PRNewswire/ --Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) (together with its subsidiaries and/or associates referred as "Sun Pharma") announced results from a Phase 1, multiple ascending-dose study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of GL0034 (Utreglutide) in obese adults. The data was exhibited in an oral presentation at the 84th Scientific Sessions of the American Diabetes Association (ADA), on June 21, 2024, in Orlando, FL. Obesity is a rapidly growing global health concern, contributing to numerous metabolic disorders, including type 2 diabetes mellitus (T2DM), cardiovascular diseases, and metabolic dysfunction-associated steatohepatitis (MASH). Effective treatments are crucial for managing obesity and its associated comorbidities. GLP-1 (glucagon-like peptide-1) receptor agonists have emerged as a promising therapeutic class for obesity. GL0034 (Utreglutide) is a novel differentiated incretin analogue with potent, long-acting agonist activity at the GLP-1 receptor. This innovative compound is under evaluation for its potential to provide significant clinical benefits beyond weight loss and gluco-metabolic benefits in individuals with obesity. "The recent GL0034 study has shown encouraging results with significant weight loss and notable improvements in lipid profiles among obese participants," said Richard E. Pratley, MD, Medical Director, AdventHealth Diabetes Institute and Senior Investigator, Diabetes Program Lead, Translational Research Institute. "This investigational therapy stands out as a potentially differentiated asset in the weight management field. The positive outcomes emphasize the potential of this treatment and set the stage for further research and development." "The promising data from our GL0034 study highlights our commitment to addressing the growing global health challenge of obesity. These findings not only demonstrate the activity of GL0034 in promoting weight loss but also underscore its potential in improving crucial cardiometabolic parameters and risk factors," said Dilip Shanghvi, Managing Director, Sun Pharma. "We are dedicated to advancing this innovative therapy to bring meaningful benefits to patients worldwide." GL0034 Oral Presentation at the ADA 2024 Scientific Sessions Safety, Tolerability, and Metabolic Effects of Once-Weekly GL0034 (Utreglutide) in Individuals with Obesity—A Multiple Ascending Dose Study. [Oral Presentation #121-OR, Friday, June 21, 2024, 05:00pm-5:15pm ET, W415C (Valencia Ballroom), Presented by Dr. Rajamannar Thennati] Healthy, obese male participants (n=24; Age 18-40; BMI ≥ 28 kg/m²) were enrolled into a fixed-dose Cohort 1 (4 x 680 µg) or an increasing-dose Cohort 2 (680/900/1520/2000 µg) and assigned to treatment groups in a 3:1 ratio, receiving 4 weekly doses of either GL0034 or a placebo. An oral glucose tolerance test (OGTT) was performed on Day -1 (baseline) and Day 23 (after the 4th dose). The results were as follows: Significant body weight reduction was observed from baseline at Day 29 and persisted through Day 43 in treatment cohorts compared to placebo. - Absolute weight loss change of –4.6 ± 1.5 (P<0.001) in Cohort 2. Both cohorts showed significant reductions in glucose AUC0-120 min during OGTT on Day 23 and dose-dependent insulin AUC0-120 min reductions, suggesting improved insulin sensitivity. HbA1c, leptin levels, and lipid levels (triglycerides, total cholesterol, non-HDL cholesterol) were reduced in the treatment cohorts. GL0034 was well-tolerated with no treatment-related discontinuations. The most common adverse events were gastrointestinal, consistent with the incretin class profile. The study was conducted in Belgium. The accumulating evidence suggests that GL0034 has a potentially differentiated profile in the evolving landscape of obesity treatment. The Phase 1 study results have demonstrated clinically meaningful weight loss, significant metabolic improvements, and a favorable tolerability profile. Notably, GL0034 has shown a novel ability to lower lipid profiles, especially triglycerides, suggesting an additional therapeutic benefit that sets it apart from other treatments. As a selective GLP-1 receptor agonist, GL0034 shows potential for enhanced therapeutic benefits. "The significant weight loss and metabolic improvements observed with GL0034 strongly support the further clinical evaluation of this novel GLP-1 receptor agonist for treating obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis, and other weight-related comorbidities. To confirm these benefits, we will conduct larger, randomized controlled studies to fully elucidate the therapeutic potential of GL0034 for patients," said Rajamannar Thennati, MD, Lead Investigator and Executive Vice President, Research & Development, Sun Pharma. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is a leading global specialty generics company with presence in Innovative products, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on "X" @SunPharma_Live. Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Logo - SOURCE Sun Pharmaceutical Industries Limited

Clinical ResultPhase 1

24 Jun 2023

·www.prnewswire.com

Sun Pharma Presents Data from First-in-Human Phase 1 Studies of GL0034 at the American Diabetes Association 83rd Scientific Sessions

GL0034 is a novel, investigational glucagon-like peptide 1 receptor agonist (GLP-1RA) being studied for the treatment of type 2 diabetes and obesity GL0034 reduced body weight after a single dose in obese individuals without diabetes Marked dose dependent reductions in body weight seen in multiple-ascending dose study in healthy individuals GL0034 was generally well tolerated in both Phase 1 studies Phase 2 clinical trials anticipated to commence in 2023 MUMBAI, India and PRINCETON, N.J., June 24, 2023 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" including its subsidiaries and/or associate companies) today announced results from two Phase 1 studies evaluating the tolerability, safety, pharmacokinetics and pharmacodynamics of GL0034, a novel long-acting GLP-1 receptor agonist, in non-obese and obese adults without diabetes. The data will be highlighted in poster presentations at the American Diabetes Association's (ADA) 83rd Scientific Sessions held from June 23-26, 2023, in San Diego, CA. In one of the studies, GL0034 reduced triglyceride levels and body weight by Day 8 after a single dose in obese individuals without diabetes. In the other study, GL0034 administered at multiple-ascending doses once weekly for up to 8 weeks was well tolerated and resulted in meaningful pharmacodynamic effects in healthy individuals with normal body weight. In this study, marked dose dependent reductions in body weight of up to 10.7% were observed following GL0034 treatment of relatively low doses for 4 to 8 weeks. Across the two Phase 1 studies, the most common adverse events occurring (≥5 participants in any dose arm) included nausea, vomiting, decreased appetite, early satiety, and dyspepsia. "The results of the Phase 1 trial of GL0034 are promising based on the safety and efficacy profile," said Richard E. Pratley, MD, Medical Director, AdventHealth Diabetes Institute and Senior Investigator, Diabetes Program Lead, Translational Research Institute. "GL0034 has a promising future in terms of weight loss and glycemic effects and based on these early results presented at ADA, GL0034 has a potential to be best in class. I look forward to learning more through further studies." "The rising incidence of obesity and diabetes places significant burden on global healthcare systems, and GLP-1 agonists have emerged as a useful option for treating these conditions with a single agent. We believe the Phase 1 data of Sun's GL0034 potentially differentiates it from approved therapies in its class. We are excited to take the product through to the next stage of development," said Dilip Shanghvi, Managing Director, Sun Pharma. GL0034 was discovered and is being developed by Sun Pharma. Further clinical studies are planned to confirm clinical safety and efficacy, including a 12-week proof of concept study in obese adults with type 2 diabetes, with non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) biomarkers, which will begin enrollment during 2023. "These Phase 1 studies suggest a potential role for GL0034 as a unique candidate to provide therapeutic benefits for obese adults," said Rajamannar Thennati, MD, Lead Investigator and Executive Vice President, Research & Development, Sun Pharma. "Initial results showed that GL0034 was generally well tolerated, and we are encouraged by the rate and durability of weight loss in these populations and look forward to proceeding to Phase 2 trials in obesity and type 2 diabetes." GL0034 Poster Presentations at the ADA 2023 Scientific Sessions A Single-Ascending Dose Study of The Novel GLP-1 Receptor Agonist GL0034 (Utreglutide) in Obese Individuals Without Diabetes. [Poster # 765-P, Sunday, June 25, 2023, 11:30am – 12:30pm PT, Hall B-C, Presented by Dr. Rajamannar Thennati] Participants (n=24; BMI ≥30 kg/m2) were randomized 3:1 to treatment with GL0034 or placebo. The cohorts achieved mean percent changes in body weight, ranging from -1.9% at the 2000 μg dose (p<0.01) to -2.5% at the highest dose (2520 μg; p<0.001) at Day 8 and sustained beyond initial treatment exposure through Day 22, compared to 0.3% at Day 8 and -0.1% at Day 22 in placebo-treated participants. Triglyceride levels were significantly decreased from baseline in participants treated with GL0034 2000 μg and 2520 μg with mean percent changes of -40.7% (2000 μg; p<0.01) and -28.0% (2520 μg; p<0.05) at Day 8, compared to an increase of 9.9% in placebo-treated individuals. The most common AEs occurring in ≥5 participants receiving GL0034 were decreased appetite, early satiety, nausea, dyspepsia, and vomiting. Safety and Tolerability of Once-Weekly GL0034 (Utreglutide) in Healthy Individuals. A Multiple-Ascending Dose Study. [Poster # 766-P, Sunday, June 25, 2023, 11:30am – 12:30pm PT, Hall B-C, Presented by Dr. Rajamannar Thennati] Participants (n=36; BMI 18–28 kg/m2) were enrolled into 3 fixed-dose or increasing-dose cohorts and were randomized 3:1 to treatment with GL0034 or placebo. The cohorts demonstrated mean percent changes in body weight, ranging from -4.5% at the lowest dose (450 µg; p<0.001) at Day 29 to -10.7% at the highest increasing dose (450/900/1520 µg; p<0.001) at Day 52, compared with -0.5% and 2.2% in placebo-treated participants. ALT levels were observed within normal range at the start of the study and were reduced during treatment with all doses of GL0034 at Day 23 and Day 51. Additionally, reductions from baseline in levels of fasting insulin were noted in cohorts 2 and 3 with corresponding improvements in HOMA-IR. The most common AEs occurring in ≥5 participants receiving GL0034 included nausea, vomiting, and decreased appetite. About GL0034 GL0034 (utreglutide) is an investigational novel glucagon-like peptide 1 receptor agonist (GLP-1RA) in development as a once-weekly, long-acting, antidiabetic medication in patients with obesity and type 2 diabetes. Sun Pharma proceeded into its first-in-human Phase 1 clinical trial based on positive results of its pre-clinical trials in which GL0034 demonstrated robust antidiabetic effects in mice, including reductions in blood glucose levels as well as body weight. Further clinical studies are planned to confirm clinical safety and effectiveness, including a 12-week proof of concept study in obese adults with type 2 diabetes, with non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) biomarkers. About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, onco-dermatology and accounts for over 16% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on Twitter @SunPharma_Live. Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. SOURCE Sun Pharmaceutical Industries Inc., USA (Sun Pharma)

Clinical ResultPhase 1Phase 2

20 Dec 2022

·www.prnewswire.com

DelveInsight Estimates a Promising Picture of Obesity Pipeline Space Landscape as Key 100+ Pharma Companies Working in the Space

The prevalence of obesity has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Obesity and the growing research and development activities to develop novel therapies to treat obesity drive the market. The Companies developing the potential therapies in the last stage of development include Novo Nordisk, Eli Lilly and Company, Saniona, and several others. LAS VEGAS, Dec. 20, 2022 /PRNewswire/ -- DelveInsight's ' Obesity Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline obesity therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the obesity pipeline domain. Key Takeaways from the Obesity Pipeline Report DelveInsight's obesity pipeline report depicts a robust space with 100+ active players working to develop 130+ pipeline therapies for obesity treatment. Key obesity companies such as 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others are evaluating new drugs for obesity to improve the treatment landscape. Promising obesity pipeline therapies in various stages of development include Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. In December 2022, Amgen announced new Phase I data from AMG 133. This first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes (NCT04478708). The MAD cohorts showed mean percent changes in body weight (BW), ranging from -7.2% at the lowest dose (140mg Q4W), to -14.5% at the highest dose (420mg Q4W) by day 85. A substantial degree of weight loss was maintained beyond the treatment period, which will be shared as part of the oral presentation. Most treatment-emergent adverse events (TEAEs) were mild and transient. The majority of the TEAEs were GI-related, with the most common being nausea and vomiting, most events resolved within 48 hours. In December 2022, Poolbeg Pharma, a clinical-stage infectious disease company, acquired the exclusive license from InsuCaps to use its proprietary microencapsulation and nanoencapsulation oral delivery technologies in metabolic syndrome-related diseases, including obesity, pre-diabetes, and diabetes. In November 2022, Rhythm Pharmaceuticals, Inc. announced that Great Britain's Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older. In November 2022, Reviva Pharmaceuticals Holdings, Inc. announced the issuance of a patent covering the composition of matter for RP1208 in Canada, adding to its existing protection in key markets around the world. The Canadian patent covers the compositions of novel phenylcycloalkylmethylamine derivatives and the use of the compositions for the treatment of obesity, related co-morbid conditions, and depression and related co-morbid conditions. In October 2022, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity or overweight with weight-related comorbidities. In September 2022, Rivus Pharmaceuticals Inc. announced the completion of a USD 132 million Series B financing led by RA Capital Management with participation from Bain Capital Life Sciences, BB Biotech AG, and existing investors Longitude Capital, Medicxi, and RxCapital. This financing will further support the clinical advancement of lead candidate HU6, a first-in-class Controlled Metabolic Accelerator (CMA) designed to treat cardio-metabolic disease by addressing obesity, a primary driver of disease. In June 2022, LG Chem's new drug for treating genetic obesity received additional ODD (Orphan Drug Designation) from the US FDA. LG Chem announced on the 16th that the FDA recently granted ODD to ' LB54640' for the treatment of 'POMC (Proopiomelanocortin) deficiency.' In April 2022, Saniona announced that it paused the Phase IIb clinical trials testing Tesomet for people with Prader–Willi syndrome (PWS) and hypothalamic obesity (HO). The decision "is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The company also announced a reprioritization and restructuring effort to immediately reduce operating expenses while maximizing cash resources. Request a sample and discover the recent advances in obesity drug treatment @ Obesity Pipeline Report The obesity pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage obesity drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the obesity clinical trial landscape. Obesity Overview Obesity is a chronic disease that causes abnormal or excessive fat accumulation or adipose tissue in the body, posing a health risk. It is caused by an imbalance between calories consumed and calories burned. The factors responsible for the causes of obesity include heredity, a sedentary lifestyle, excessive fat, sugar consumption (energy-dense meals), certain medications, and endocrine issues. Changes in the environment or society, as well as in behavior and culture, all directly impact. Obesity symptoms go beyond an increase in body fat. It can cause skin issues, shortness of breath, sleeping difficulties, and other symptoms. Some obesity symptoms have even been linked to an increased risk of developing certain diseases and disorders. In some cases, these can be life-threatening or even fatal. Find out more about drugs for obesity @ FDA-approved Obesity Drugs A snapshot of the Obesity Pipeline Drugs mentioned in the report: Learn more about the emerging obesity pipeline therapies @ Obesity Clinical Trials Obesity Therapeutics Assessment The obesity pipeline report proffers an integral view of obesity emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Obesity Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Glucagon like peptide 1 receptor agonists, Gastric inhibitory polypeptide receptor agonists, Beta 1 adrenergic receptor antagonists, Biogenic monoamine uptake inhibitors, Lipolysis modulators, Alpha-glucosidase inhibitors, Amylase inhibitors, Lipase inhibitors, Glucagon like peptide 1 receptor agonists, Glucagon receptor agonists, Islet amyloid polypeptide replacements Key Obesity Companies: 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others. Key Obesity Pipeline Therapies: Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. Dive deep into rich insights for new drug for obesity treatment; visit @ Obesity Medications Table of Contents For further information on the obesity pipeline therapeutics, reach out @ Obesity Drug Treatment Related Reports Obesity Epidemiology Forecast Obesity Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the obesity epidemiology trends. Obesity Market Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, among others. Hypothalamic Obesity Market Hypothalamic Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. Hypothalamic Obesity Pipeline Hypothalamic Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. HET Obesity/POMC Deficiency Obesity Pipeline HET Obesity/POMC Deficiency Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. HET Obesity/POMC Deficiency Obesity Market HET Obesity/POMC Deficiency Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | CAR-T Pipeline Insight | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Outlook Report | Crows Feet Market Insight | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market Related Healthcare Blogs Obesity: A Global Concern Weight Loss and Obesity Market Obesity Treatment Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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100 Deals associated with Utreglutide

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	-	Sun Pharmaceutical Industries Ltd.	24 Jun 2023
Obesity	Phase 1	-	Sun Pharmaceutical Industries Ltd.	24 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACTRN12624000322538 (ADA2024) Manual	Phase 1	Obesity	12	GL0034 (Utreglutide) (cohort 1)	zdncrifurw(sjyzyibttl) = djqpdyeqpv hqeinxhyrb (jyhwdstyce, 1.7)	Positive	14 Jun 2024
				GL0034 (Utreglutide) (cohort 2)	zdncrifurw(sjyzyibttl) = gkmdncyiwl hqeinxhyrb (jyhwdstyce, 1.5)
ADA2024	Not Applicable	Obesity	-	GL0034 (Utreglutide)	xrbwheglxd(iildzuwitk) = Most common adverse events (AE) were gastrointestinal (GI) with dose-dependent nausea, decreased appetite and vomiting. One individual with a GI related serious AE rapidly recovered upon treatment with intravenous rehydration. haceicbugl (nrhgoonmog )	-	14 Jun 2024
				Placebo
ADA2024	Not Applicable	-	-	GL0034	growanljbx(zymdwjnssk) = fnijsitnev dfaicwypjn (puuecrjhsq )	-	14 Jun 2024
				Semaglutide (Sema)	growanljbx(zymdwjnssk) = allgqcbuas dfaicwypjn (puuecrjhsq )
EASD2023	Phase 1	Obesity	24	Utreglutide 2,520 µg	uhxlmbhmji(jdmhxiwjfu) = The common utreglutide-related adverse events were gastrointestinal with dose-dependent nausea, decreased appetite and vomiting. No injection site reactions or any other adverse events were noted. gvryulyath (dzogpthvpn ) View more	Positive	03 Oct 2023
ADA2023	Not Applicable	Obesity	24	GL0034 (Utreglutide) 1,520 μg	mceajlkknh(exksndxbgn) = Most common GL-related adverse events were gastrointestinal with dose-dependent nausea, decreased appetite and vomiting nyrudtdyye (uewijhwrqj ) View more	Positive	20 Jun 2023
				GL0034 (Utreglutide) 2,000 μg

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