A Thorough QTc Evaluation of the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel Study With a Nested Crossover Design for Positive Control With Moxifloxacin Administration

This study will investigate the effect of multiple doses of cotadutide on the cardiac activity (QTc interval) of healthy participants.

Start Date03 Jan 2023

Sponsor / Collaborator

AstraZeneca PLC

EUCTR2021-005484-53-GR / Unknown statusPhase 2

A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis - PROXYMO-ADVANCE

Start Date09 Sep 2022

Sponsor / Collaborator

AstraZeneca AB

NCT05517226 / TerminatedPhase 1

A Phase I, Parallel-group, Multi-center, Open-label, Investigation of the Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Injection of Cotadutide in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal hepatic function.

Start Date06 Sep 2022

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Cotadutide

100 Translational Medicine associated with Cotadutide

100 Patents (Medical) associated with Cotadutide

Literatures (Medical) associated with Cotadutide

01 Mar 2024·Peptides

Cotadutide (GLP-1/Glucagon dual receptor agonist) modulates hypothalamic orexigenic and anorexigenic neuropeptides in obese mice

Article

Author: Mandarim-de-Lacerda, Carlos A ; Marinho, Thatiany Souza ; Aguila, Marcia Barbosa ; Reis, Thiago Santos ; Spezani, Renata

The hypothalamic neuropeptides linked to appetite and satiety were investigated in obese mice treated with cotadutide (a dual receptor agonist of glucagon-like peptide 1 (GLP-1R)/Glucagon (GCGR)). Twelve-week-old male C57BL/6 mice were fed a control diet (C group, n = 20) or a high-fat diet (HF group, n = 20) for ten weeks. Each group was further divided, adding cotadutide treatment and forming groups C, CC, HF, and HFC for four additional weeks. The hypothalamic arcuate neurons were labeled by immunofluorescence, and protein expressions (Western blotting) for neuropeptide Y (NPY), proopiomelanocortin (POMC), agouti-related protein (AgRP), and cocaine- and amphetamine-regulated transcript (CART). Cotadutide enhanced POMC and CART neuropeptides and depressed NPY and AGRP neuropeptides. In addition, gene expressions (RT-qPCR) determined that Lepr (leptin receptor) and Calcr (calcitonin receptor) were diminished in HF compared to C but enhanced in CC compared to C and HFC compared to HF. Besides, Socs3 (suppressor of cytokine signaling 3) was decreased in HFC compared to HF, while Sst (somatostatin) was higher in HFC compared to HF; Tac1 (tachykinin 1) and Mc4r (melanocortin-4-receptor) were lower in HF compared to C but increased in HFC compared to HF. Also, Glp1r and Gcgr were higher in HFC compared to HF. In conclusion, the findings are compelling, demonstrating the effects of cotadutide on hypothalamic neuropeptides and hormone receptors of obese mice. Cotadutide modulates energy balance through the gut-brain axis and its associated signaling pathways. The study provides insights into the mechanisms underlying cotadutide's anti-obesity effects and its possible implications for obesity treatment.

01 Feb 2024·Neurogastroenterology and motility

The role of gastric function in control of food intake (and body weight) in relation to obesity, as well as pharmacological and surgical interventions

Review

Author: Camilleri, Michael

Abstract:

Purpose:

The objectives of this review are to summarize the role of gastric motor functions in the development of satiation (defined broadly as postprandial fullness) and satiety (reduced appetite or postponing desire to eat after a meal) and their impact on weight change. The specific topics are the methods of measurement of gastric emptying and accommodation and their impact on food intake, satiation, and satiety. A second focus contrasts bariatric surgery to endoscopic gastroplasty that alter gastric emptying and incretin responses in markedly divergent manners.

Background:

The hormone, GLP‐1, retards gastric emptying and increases gastric accommodation through vagally‐mediated effects. Indeed, these effects provide the basis for the association of altered gastric emptying in the appetite and weight loss responses to pharmacological interventions particularly by those acting on receptors of incretin agonists such as liraglutide and the dual agonists, tirzepatide and cotadutide, all of which retard gastric emptying. In fact, retardation of gastric emptying and gastrointestinal adverse effects have been shown to contribute in part to the weight loss in response to this class of pharmacological agents.

Summary:

The motor functions of the stomach are relevant to postprandial fullness and to interventions aimed at weight loss in people with obesity.

01 Jan 2024·European journal of pharmacology

OXM-104, a potential candidate for the treatment of obesity, NASH and type 2 diabetes

Article

Author: Karsdal, Morten Asser ; Kayed, Ashref ; Melander, Simone Anna ; Andreassen, Kim Vietz ; Henriksen, Kim

OBJECTIVE:

Dual glucagon-like peptide-1 (GLP-1) and glucagon receptor agonists are therapeutic agents with an interesting liver-specific mode of action suitable for metabolic complications. In this study, dual GLP-1 and glucagon receptor agonist OXM-104 is compared head-to-head with the once-daily dual GLP-1 and glucagon receptor agonist cotadutide and GLP-1 receptor agonist semaglutide to explore the metabolic efficacy of OXM-104.

METHODS:

The in vitro potencies of OXM-104, cotadutide and semaglutide were assessed using reporter assays. In addition, in vivo efficacy was investigated using mouse models of diet-induced obesity (DIO mice), diabetes (db/db mice) and diet-induced NASH mice (MS-NASH).

RESULTS:

OXM-104 was found to only activate the GLP-1 and glucagon with no cross-reactivity at the (GIP) receptor. Cotadutide was also found to activate the GLP-1 and glucagon receptors, whereas semaglutide only showed activity at the GLP-1 receptor. OXM-104, cotadutide, and semaglutide elicited marked reductions in body weight and improved glucose control. In contrast, hepatoprotective effects, i.e., reductions in steatosis and fibrosis, as well as liver fibrotic biomarkers, were more prominent with OXM-104 and cotadutide than those seen with semaglutide, demonstrated by an improved NAFLD activity score (NAS) by OXM-104 and cotadutide, underlining the importance of the glucagon receptor.

CONCLUSION:

These results show that dual GLP-1 and glucagon receptor agonism is superior to GLP-1 alone. OXM-104 was found to be a promising therapeutic candidate for the treatment of metabolic complications such as obesity, type 2 diabetes and NASH.

News (Medical) associated with Cotadutide

17 Apr 2024

·www.biospace.com

NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

Phase 1 Clinical Trial Timelines Significantly Accelerated Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024 First Patient Dosed in the Multiple Ascending Dose Part 2 Expected in the Third Quarter of 2024 CAMBRIDGE, Mass., April 17, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced dosing of the first patient in the single ascending dose (SAD) Part 1 of its two-part Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. "Dosing of the first patient in this trial is a groundbreaking achievement in the development of DA-1726, marking the first time this cardiometabolic asset will be tested in humans, bringing it one step closer to treating obesity, utilizing a novel mechanism as compared to other currently available treatments," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "Although the main goal of the SAD part of this study is to assess the safety and tolerability of DA-1726, based on pre-clinical evidence, we believe that it may have a better tolerability pro currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors, reducing food intake while also increasing energy expenditure. Specifically, in pre-clinical mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy®) and resulted in similar weight reduction while consuming more food compared to tirzepatide (Zepbound™). Notably, we have significantly accelerated the timelines for the Phase 1 trial, and look forward to dosing the first patient in the multiple ascending dose (MAD) Part 2 in the third quarter of this year. Additionally, we now expect to report top-line data from the SAD Part 1 in the third quarter of 2024, and the MAD Part 2 in the first quarter of 2025." The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The Part 1 SAD study is expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo. Part 2 is designed as a MAD study, expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo. The primary endpoint will assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and MASH that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in preclinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue). About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. For more information, please visit . Forward Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; our ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 marshall.woodworth@neurobopharma.com Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com Company Codes: NASDAQ-NMS:NRBO

Phase 1Clinical Result

14 Mar 2024

·firstwordpharma.com

Madrigal's Rezdiffra clinches first FDA approval for MASH

After years of clinical failures and FDA rejections in the liver disease space, Madrigal Pharmaceuticals has finally taken gold in the race for the first approval in metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). Specifically, the FDA granted Rezdiffra (resmetirom) accelerated approval to treat adults with non-cirrhotic MASH and moderate-to-advanced liver fibrosis consistent with stages F2 to F3 fibrosis, in conjunction with diet and exercise. A biopsy is not required for diagnosis.The THR-β selective agonist will be available to US patients starting April, after months of building excitement. In a 70-physician FirstWord poll conducted last month, 30% of respondents said they were very enthusiastic about prescribing the drug (see: Physician Views Results: Potential new NASH drug gets positive assessment from US docs).This greenlight will most likely open the MASH floodgates. Despite the difficulty designing drugs for the heterogeneous liver disease, which has a variety of etiologies and paths of progression, a series of promising candidates across multiple mechanisms have lined up behind Rezdiffra, such as FGF21 analogues and GLP-1 agonists. For more on the development landscape, see Spotlight On: MASH pipeline holds promise of multiple mechanisms for disease management.Rezdiffra’s approval comes, in part, because it was able to demonstrate efficacy without the safety concerns that sunk Intercept Pharmaceuticals’ obeticholic acid. Treatment defining dataRezdiffra, a once-daily, oral candidate secured FDA approval on Thursday thanks to 52-week data from the pivotal MAESTRO-NASH study, which met the co-primary endpoints of MASH resolution with no worsening of fibrosis, and at least a one-stage reduction in fibrosis with no worsening of non-alcoholic fatty liver disease (NAFLD) activity score. According to results, 25.9% of patients who received the 80mg dose, and 29.9% in the 100mg arm, achieved MASH resolution endpoint, compared with 9.7% for placebo. For fibrosis improvement, the rates were 24.2% and 25.9% for the low- and high-dose arms, respectively, versus 14.2% for placebo.Most of the reported side effects were mild-to-moderate, with a roughly 11-13% serious adverse event rate across each of the three cohorts. There was no incidence of drug-induced liver injury, increases in bone fractures or adverse events linked to thyroid hormone effects outside the liver such as heart rate changes.Rezdiffra’s label reflects the clinical safety results. The drug does not carry a boxed warning, and its label notes that the most common side effects are diarrhoea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness.First success of many failuresMadrigal’s journey to FDA approval comes after the failures of several other drug developers to show both safety and efficacy of their MASH programmes, most notably that of obethicholic acid from Intercept.The biotech received its first complete response letter for the candidate in 2020, which said that the predicted benefit of obethicholic acid "does not sufficiently outweigh the potential risks.” Three years later, FDA again rejected the treatment, saying that approval would require, at a minimum, the successful completion of a long-term outcomes Phase III trial.Large pharmas have also seen their fair share of setbacks in the disease. Last year, Novartis ended a partnership with Pliant Therapeutics to develop the latter's integrin αVβ1 inhibitor PLN-1474 for MASH.Pfizer and AstraZeneca have both recently trimmed their MASH pipelines. The UK drugmaker terminated development of late-stage injectable GLP-1/glucagon co-agonist cotadutide last year, while the US pharma has ended at least two MASH programmes in the last three years: ketohexokinase inhibitor PF-06835919, and oral GLP-1 receptor agonist danuglipron. MASH future looks brightNow that Madrigal has shown approval is possible, drugmakers waiting in the wings may be more bullish on the prospects for their own programmes. FirstWord spoke with 89bio chief medical officer Hank Mansbach earlier this week on the chances of accelerated approval for FGF21 analogue pegozafermin, for which it just launched a Phase III trial. At the time, Mansbach said an approval for resmetirom would give the company a confidence boost. Other companies who have shared promising mid-stage data include fellow FGF21 developer Akero Therapeutics, Ionis Pharmaceuticals’ antisense inhibitor, Sagimet Biosciences and its fatty acid synthase (FASN) inhibitor, partners Boehringer Ingelheim and Zealand Pharma for their dual GLP-1 and glucagon agonist, as well as Viking Therapeutics, whose candidate has the same mechanism of action as Madrigal’s.

Drug ApprovalPhase 3Accelerated ApprovalClinical Result

29 Feb 2024

·www.prnewswire.com

NeuroBo Pharmaceuticals Receives First Site IRB Approval for Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

First Patient Expected to be Randomized in the Second Quarter of 2024 CAMBRIDGE, Mass., Feb. 29, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of Miami, in Hialeah, FL, to proceed with the Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The company expects to randomize the first patient in the second quarter of this year. "With this first site IRB approval, we have achieved another significant milestone in the development of DA-1726, bringing the program one step closer to the clinic," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "This promising cardiometabolic asset may have a better tolerability profile than currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors. As previously reported, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy®), and its administration resulted in similar weight reduction while consuming more food compared to tirzepatide (Zepbound™). We look forward to working closely with our contract research organization (CRO) partner and our investigators, such as Dr. Prezioso, to start randomizing patients in the second quarter of this year. We expect to report top-line data from the single ascending dose (SAD) Part 1 in the first half of 2025 and the multiple ascending dose (MAD) Part 2 in the second half of 2025." The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 will be a single ascending dose (SAD) study, expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo. Part 2 will be a multiple ascending dose (MAD) study, expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo. The primary endpoint will assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and NASH that is to be administered once weekly subcutaneously. DA-1726 as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in preclinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue). About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. For more information, please visit . Forward Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between our product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; our ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; effects of changes in applicable laws or regulations; effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Interim Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc.

Phase 1

100 Deals associated with Cotadutide

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KEGG	Wiki	ATC	Drug Bank
D11304	-	-	DB15194

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis	Phase 3	US	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	US	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	JP	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	JP	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	AR	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	AR	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	AU	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	AU	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	AT	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	AT	AstraZeneca AB	12 Jul 2022

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04515849 (EASD2023)	Phase 2	Diabetic Nephropathies	-	Cotadutide 100 µg	maslzvonku(sfiovxpnum) = rymkxwovxv yjymifkdcn (vblzpzcilr, -52.5 to -23.9) View more	Positive	03 Oct 2023
				Cotadutide 300 µg	depapbfrms(ssaposynvq) = kjtjekeuoy knmcaejiyg (pyytvnchkv ) View more
ERA2023	Phase 2	Chronic Kidney Diseases	248	Cotadutide	btydpujybv(lojcxxrxpt) = zgwbqmtsni daawkwhjuk (pknkmawsmy, -52,5, - 23.9) View more	-	15 Jun 2023
NAASO2022	Phase 2	Obesity	18	Cotadutide	uzghdsgbdq(dcroczzoob) = gvxiftlnap obojwurdol (ssmuxrctoh ) View more	-	21 Nov 2022
				Placebo	uzghdsgbdq(dcroczzoob) = ragklifwmr obojwurdol (ssmuxrctoh ) View more
NCT03550378 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	41	Cotadutide	dggvqzqjsr(vcddkiwqkl) = vjemuvjljt xulscdqppx (ojwsngvavl ) View more	Positive	11 Apr 2022
				Placebo	dggvqzqjsr(vcddkiwqkl) = caolmkorvl xulscdqppx (ojwsngvavl ) View more
NCT03444584 (EASD2021)	Phase 2	Diabetes Mellitus, Type 2 Add-on	49	Cotadutide+Dapagliflozin+Metformin	cmgnzzyklj(bhmsnzuggw) = iftzeyymup hnfiophnar (tgvybnmqha ) View more	Positive	30 Sep 2021
NCT03645421 (Pubmed) Manual	Phase 1/2	Diabetes Mellitus, Type 2 \| Overweight \| Obesity	61	cotadutide	khncdnwlvl(xfhjvcnnaa) = no serious adverse events. htifzoukqi (rcdxzkuceh ) View more	Positive	01 Aug 2021
				Placebo
ADA2021	Not Applicable	Type 2 diabetes mellitus in obese	-	Cotadutide	nwwnaqcgqu(nupmgnqmfo) = ktzsmnsozw kjrjvtrrvb (bltyfvmbnq, -4.85%, - 3.10%) View more	-	01 Jun 2021
				Placebo	nwwnaqcgqu(nupmgnqmfo) = myjbtbnkhp kjrjvtrrvb (bltyfvmbnq, -2.66%, - 0.13%) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetic Nephropathies	41	Cotadutide	dqjewtlsph(rmppvuvwrx) = xiliyrodcf kjsdwzmkbc (weujksgnui ) View more	-	01 Jun 2021
				Placebo	mjrganwgnf(mhhkikeclb) = njaijonplw crwmojwlbn (gckimwjqsv )
NCT03596177 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	28	Placebo (Placebo)	cnymawcfzl(lutmzlxxtg) = wyyqdcqass nqnrqjlfvu (emquyohstd, zmxgijuvot - xzoideyjgw) View more	-	15 Jan 2021
				Placebo+MEDI0382 (MEDI0382)	cnymawcfzl(lutmzlxxtg) = jnigolihme nqnrqjlfvu (emquyohstd, uxwmhagfvf - cdhgsipeic) View more
NCT03235050 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	834	Placebo+Metformin (Placebo)	fgpekxmtfw(ispkhcxhkx) = tttbwlcxjo ycwlszgisl (qioprlooyn, fxdmkksyjb - ukiyslsjpt) View more	-	20 Jul 2020
				MEDI0382+Metformin (MEDI0382 100 mcg)	fgpekxmtfw(ispkhcxhkx) = tqgnqfcued ycwlszgisl (qioprlooyn, ghpjpzwcei - npmqgkfbxu) View more

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