A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese participants with overweight/obesity with or without T2DM.

Start Date15 Jun 2025

Sponsor / Collaborator

Eccogene (Shanghai) Co., Ltd

NCT06996886

/ RecruitingPhase 1

An Open-Label, Randomized, Four-Treatment, Four-Period, Single-Dose Crossover Study in Healthy Participants to Assess the Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (F1, F3, F4)

The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.

Start Date22 May 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT06942936

/ RecruitingPhase 1

An Open-label, Fixed-sequence and Two-part Study to Assess the Impact of Multiple Doses of Itraconazole on the Pharmacokinetics of AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on the Pharmacokinetics of Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants

The purpose of this study is to assess the impact of multiple doses of itraconazole on the pharmacokinetics (PK) of AZD5004 in healthy participants (Part A), and to assess the impact of multiple doses of AZD5004 on the PK of Combined Oral Contraceptives (COCs) in healthy female participants (Part B).

Start Date28 May 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with ECC-5004

100 Translational Medicine associated with ECC-5004

100 Patents (Medical) associated with ECC-5004

Literatures (Medical) associated with ECC-5004

01 May 2025·OBESITY SURGERY

Efficacy and Safety of GLP- 1 Receptor Agonists in the Management of Weight Recurrence or Suboptimal Clinical Response after Undergoing Metabolic Bariatric Surgeries: A Meta-Analysis

Review

Author: Arrowaili, Arief

BACKGROUND:

There is a pressing requirement to formulate innovative approaches for addressing inadequate weight loss or recurrence in individuals following metabolic bariatric surgery (MBS). Glucagon-like peptide- 1 (GLP- 1) analogues such as liraglutide and semaglutide have been formulated for treating type 2 diabetes or managing obesity. In this systematic review and meta-analysis, we aimed to pool the results from all available studies on GLP- 1 agonists to assess the efficacy of these drugs in weight recurrence or suboptimal clinical response of patients who underwent MBS.

METHODS:

We searched PubMed, Scopus, and Web of Science from inception till October 2024 for articles that fulfil our eligibility to be included in the systematic review and meta-analysis investigating the use of GLP- 1 agonists in the management of weight recurrence or suboptimal clinical response in patients who underwent MBS. The search strategy was as follows: "Liraglutide" OR "Semaglutide" OR "Tirzepatide" OR "GLP- 1" OR "Glucagon like peptide" AND "Weight" AND "Bariatric" OR "Sleeve" OR "Banding" OR "Roux-en-Y bypass. We used the mean difference (MD) to compare between continuous variables at a confidence interval (CI) of 95%, and p-value of 0.05.

RESULTS:

The use of GLP- 1 agonists (liraglutide, semaglutide, and tirzepatide) was associated with a statistically significant decrease in the weight of the included patients showing an overall MD = 8.07 kg (95%CI: 5.5, 10.64, p < 0.00001) and I² = 44%, p = 0.04. Moreover, these drugs (liraglutide, and semaglutide) showed significantly reduced body mass index (BMI) after treatment with overall MD = 4.42 kg/m² (95%CI: 3.42, 5.42, p < 0.00001), and I² = 67%, p = 0.0005. Compared with control group, the use of GLP- 1 agonists was associated with reduced weight with MD = - 9.19% (95%CI: - 10.81, - 7.58, p < 0.00001) and I² = 0%. However, no difference was observed between both groups regarding BMI change with MD = - 1.97% (95%CI: - 4.65, 0.71, p = 0.15).

CONCLUSION:

GLP- 1 agonists such as liraglutide and semaglutide effectively lower body weight and BMI in patients who suffer from weight recurrence or suboptimal clinical response after undergoing MBS. However, future studies are still warranted to investigate the most appropriate protocols for management.

01 Apr 2025·ARCHIV DER PHARMAZIE

Unveiling the Therapeutic Potential of Dulaglutide in Mitigating Tacrolimus‐Induced Nephrotoxicity Through Targeting the miR‐22/HMGB‐1/TLR4/MyD88/NF‐κB Trajectory

Article

Author: Shalaby, Heba Nasr ; Fakhr Eldeen, Rasha R. ; Abdelhady, Rasha ; Elhemely, Mai Abdallah ; Sayed, Rabab H. ; Arab, Hany H. ; Nawwar, Dalia A.

ABSTRACT:

Tacrolimus (Tac) is an immunosuppressive drug used to reduce the risk of allograft rejection; however, it can induce renal injury. High mobility group box 1 (HMGB‐1) protein, which induces inflammation through the aberrant stimulation of the Toll‐like receptor 4 (TLR4)/myeloid differentiation primary response protein (MyD88)/nuclear factor kappa B (NF‐κB) trajectory, could represent a molecular target for alleviating Tac‐induced renal damage. The present study aimed to investigate the potential protective role of the GLP‐1 agonist, dulaglutide (Dula), against Tac‐induced nephrotoxicity in rats. Rats were administered Tac (5 mg/kg/day) and vehicle or Dula (0.2 mg/kg once a week) for 14 days. Treatment with Dula reduced serum creatinine plus blood urea nitrogen and attenuated Tac‐induced renal histopathological changes. Dula treatment also hampered renal inflammation and restored redox homeostasis, as indicated by remarkably reduced tumor necrosis factor‐alpha (TNF‐α), interleukin‐1β (IL‐1β), malondialdehyde (MDA), and NADPH oxidase 1 levels alongside marked replenishment in reduced glutathione (GSH) content. These effects were mediated through the upregulation of miR‐22 expression and the consequent inhibition of the HMGB‐1/TLR4/MyD88/NF‐κB trajectory. Collectively, Dula has been demonstrated to protect rats against Tac‐induced nephrotoxicity by reducing inflammation, restoring redox homeostasis, and modulation of the miR‐22/HMGB‐1/TLR4/MyD88/NF‐κB trajectory. Dula may be beneficial clinically in preventing Tac‐induced renal injury.

04 Mar 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

The promise of glucagon-like peptide 1 receptor agonists (GLP-1RA) for the treatment of obesity: a look at phase 2 and 3 pipelines

Review

Author: Madsbad, Sten ; Holst, Jens J

INTRODUCTION:

GLP-1-based therapies have changed the treatment of overweight/obesity. Liraglutide 3.0 mg daily, the first GLP-1 RA approved for treatment of overweight, induced a weight loss of 6-8%, Semaglutide 2.4 mg once weekly improved weight loss to about 12-15%, while the dual GIP/GLP-1 receptor agonist tirzepatide once weekly has induced a weight loss of about 20% in obese people without diabetes.

AREAS COVERED:

This review describes results obtained with GLP-1 mono-agonists, GLP-1/GIP dual agonists, GLP-1/glucagon co-agonists, and the triple agonist retatrutide (GIP/GLP-1/glucagon), which have shown beneficial effect both on body weight and steatotic liver disease. A combination of semaglutide (a GLP-1 agonist) and cagrilintide (a long-acting amylin analogue) for weekly administration is currently in phase III development, and so is oral semaglutide and several non-peptide small molecule GLP-1 agonists for oral administration. The adverse events with the GLP-1-based therapies are primarily gastrointestinal and include nausea, vomiting, obstipation, or diarrhea, which often can be mitigated by slow up titration.

EXPERT OPINION:

The GLP-1-based therapies will change the treatment of obesity and its comorbidities including steatotic liver disease in the future. Outstanding question is maintenance of the weight loss, possibly pharmacological treatment needs to be life-long.

News (Medical) associated with ECC-5004

18 Jun 2025

·www.einpresswire.com

Eccogene Announces First Patient Dosed in Phase 1b Trial of AZD5004/ECC5004, a Novel Oral GLP-1 Receptor Agonist, in China

BOSTON and SHANGHAI, June 18, 2025 (GLOBE NEWSWIRE) -- Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, today announced that the first patient has been dosed in a Phase 1b clinical trial of AZD5004/ECC5004 in China. The earlier Phase 1 trial of AZD5004/ECC5004 was conducted in the U.S. only and this trial in China is a key milestone to support local regulatory requirements. AZD5004/ECC5004 is an investigational oral small molecule GLP-1 receptor agonist, which is currently being investigated for the treatment of type 2 diabetes and obesity or overweight with at least one comorbidity. This molecule was discovered by Eccogene and licensed globally to AstraZeneca. Eccogene retains co-development and co-commercialization rights in China. “We recognize the significant unmet need in China that exists in type 2 diabetes and obesity/overweight, and the need to deliver new therapies to these patients,” said Jingye Zhou, Chief Executive Officer of Eccogene. “Together with our partner AstraZeneca, we are advancing the development of AZD5004/ECC5004 in China with the aim of creating a convenient once-daily oral GLP-1RA with no food-related restrictions. This milestone reinforces Eccogene’s position as an innovator in advancing novel, differentiated oral therapies for cardiometabolic diseases with broad commercial potential.” Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, commented: “The start of this Phase 1b trial in China marks an important milestone in the extensive clinical program for AZD5004/ECC5004, an oral small molecule GLP-1RA which has significant potential as part of our extensive CVRM portfolio. Overweight and obesity are key drivers of cardiometabolic disease, and we are developing AZD5004/ECC5004 to be a part of the solution for this complex and urgent public health issue, both as a monotherapy and in combination with other agents.” AstraZeneca is currently conducting two global Phase 2b multicenter trials— VISTA ( NCT06579092 ) and SOLSTICE ( NCT06579105 )—to evaluate the efficacy and safety of AZD5004/ECC5004 administered orally, once daily in participants who are living with obesity or overweight with at least one weight-related comorbidity, and type 2 diabetes, respectively. About Eccogene Eccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions. Since its founding, Eccogene has been dedicated to discovering safer and more effective oral therapies that can be used alone or synergistically with a GLP-1 receptor agonist to treat conditions beyond obesity. The Company’s diverse pipeline of small molecule candidates leverages its world-class expertise in translational research, small molecule drug discovery, and a deep understanding of cardiometabolic diseases. For more information, please visit www.eccogene.com or follow the Company on LinkedIn . Media Contact Amy Bonanno Lyra Strategic Advisory abonanno@lyraadvisory.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1Phase 2

18 Mar 2025

·www.drugs.com

GLP-1 RA Use Tied to Better Kidney Transplant Outcomes in Patients With Diabetes

TUESDAY, March 18, 2025 -- Glucagon-like peptide-1 receptor agonist (GLP-1 RA) use is associated with better graft and patient survival among kidney transplant recipients with diabetes , according to a study published online March 5 in The Lancet Diabetes & Endocrinology . Babak J. Orandi, M.D., Ph.D., from New York University in New York City, and colleagues examined the real-world safety and effectiveness of GLP-1 RA use in kidney transplant recipients with diabetes. The analysis included 18,016 kidney transplant recipients with diabetes (2013 through 2020) covered by Medicare, of whom 10.9 percent had at least one GLP-1 RA prescription filled posttransplant. The researchers found that the five-year unadjusted cumulative incidence of death-censored graft loss from a cohort matched on survival time before GLP-1 RA initiation was 6.0 percent for GLP-1 RA users and 10.7 percent for nonusers. Based on a cohort matched on survival time before GLP-1 RA initiation, the five-year unadjusted cumulative incidence for mortality was 17.0 percent for GLP-1 RA users and 25.8 percent for nonusers. Use of GLP-1 RAs was associated with lower incidence of death-censored graft loss (adjusted subhazard ratio, 0.51) and lower mortality (adjusted hazard ratio, 0.69). GLP-1 RA use was not associated with safety end points, with the exception of diabetic retinopathy (adjusted hazard ratio, 1.49). "Our study results are the strongest evidence to date that GLP-1 agonist drugs are largely safe and effective tools for addressing type 2 diabetes in kidney transplant recipients," Orandi said in a statement. Several authors disclosed ties to the pharmaceutical industry.

Clinical Result

06 Mar 2025

·www.drugs.com

GLP-1 Drugs Improve Outlook For Kidney Transplants

THURSDAY, March 6, 2025 -- GLP-1 drugs like Ozempic can help kidney transplant patients avoid organ failure and live longer, a new study suggests. The drugs help manage patients’ type 2 diabetes and promote weight loss, both of which improve the chances of a successful kidney transplant, researchers added. Kidney transplant patients prescribed GLP-1 drugs were 49% less likely to experience organ failure, in which their new kidney stops working and they have to resume dialysis, researchers reported March 3 in The Lancet . Patients taking GLP-1 drugs also had a 31% lower risk of dying within five years of starting on the medication, researchers said. “Our study results are the strongest evidence to date that GLP-1 agonist drugs are largely safe and effective tools for addressing type 2 diabetes in kidney transplant recipients,” lead researcher Dr. Babak Orandi said in a news release. He's a transplant surgeon and obesity medicine specialist at NYU Langone Health in New York City. Glucagon-like peptide-1 (GLP-1) drugs mimic the GLP-1 hormone, which helps control insulin and blood sugar levels, decreases appetite and slows digestion of food. GLP-1 drugs include semaglutide, liraglutide and dulaglutide, now marketed as Ozempic , Wegovy , Saxenda , Victoza and Trulicity . Both diabetes and obesity increase the risk of a kidney transplant going bad, researchers said. Given that, it makes sense that GLP-1 drugs might help. However, known side effects of the drugs include inflammation of the pancreas and liver problems, which might work against a kidney transplant, researchers noted. There’s also been concern that GLP-1 drugs might increase the risk of a rare form of thyroid cancer in patients taking immune-suppressing drugs to prevent transplant rejection, researchers added. To check the risks and benefits of the drugs, researchers reviewed the medical records of more than 18,000 kidney transplant recipients with diabetes between 2013 and 2020. Of those, more than 1,900 had been prescribed a GLP-1 drug. Although the study found benefits, it also discovered some increased risks associated with the drugs. Kidney transplant patients taking GLP-1 drugs had a 49% greater risk of developing diabetic retinopathy, a potentially blinding condition caused by damage to the light-sensitive tissue lining the back of the eyes. “Our findings also show that while the benefits of GLP-1 drugs are significant, their use does come with some added risk of diabetic retinopathy, suggesting that physicians need to carefully monitor the eye health of kidney transplant recipients with diabetes who are started on these drugs,” senior investigator Mara McAdams-DeMarco said in a news release. She is an associate professor of surgery and population health at NYU Grossman School of Medicine. Orandi said this risk can be managed by screening for diabetic retinopathy in transplant patients, particularly in people with uncontrolled diabetes, and making sure blood sugar levels are stable before prescribing GLP-1 drugs. Doctors also might consider starting with lower doses of GLP-1 drugs and slowly increasing them for people with severe diabetes or a history of eye problems, he added. More research is needed to figure out exactly why GLP-1 drugs might help kidney transplants succeed, as well as why they increase the risk of diabetic retinopathy, researchers concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalClinical Result

100 Deals associated with ECC-5004

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	United States	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Japan	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Canada	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Germany	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Hungary	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Poland	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Slovakia	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	Spain	AstraZeneca PLC	08 Oct 2024
Diabetes Mellitus, Type 2	Phase 2	United Kingdom	AstraZeneca PLC	08 Oct 2024
Obesity	Phase 2	United States	AstraZeneca PLC	01 Oct 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05654831 (NEWS) Manual	Phase 1	Diabetes Mellitus, Type 2	-	AZD5004 50mg	zseqaiaeky(znylhvgzox): Difference = -76.6 mg/dL View more	Positive	04 Nov 2024
				Placebo
NCT05654831 (Pubmed) Manual	Phase 1	Diabetes Mellitus, Type 2	-	ECC5004/AZD5004	zibnokzgju(musrebqqri) = None cvthyaqitk (kiblucemlz ) View more	Positive	04 Nov 2024
ADA2023	Not Applicable	-	-	Exenatide via RP	bfzfvsteam(btcbqstoji) = krxvgzljgb tglpjlkivb (immamkufnq )	-	20 Jun 2023
				Byetta via endoscopic, transenteric injection	bfzfvsteam(btcbqstoji) = tofhwrydhj tglpjlkivb (immamkufnq )
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	-	GLP-1 agonist	tvhxlembno(iymqinsaqt) = yxrpxmtfyc fvbimjltyj (vqdrywxvjn ) View more	-	01 Jun 2021
				Insulin therapy	tvhxlembno(iymqinsaqt) = hreghyduph fvbimjltyj (vqdrywxvjn ) View more
EASD2014	Not Applicable	Diabetic macular oedema	125	Exenatide	xprvoixwko(efihhsehfz) = efsscayolv zyvhbsxnru (kzpyxxqgsb, 1 - 32) View more	Positive	18 Sep 2014
				Liraglutide	fvesfgnngm(sclosifoaz) = pczjnkytzr dbhqcijywl (edlhusncyj )
VARIATION study (EASD2014)	Not Applicable	Diabetes Mellitus, Type 2	80	Basal insulin + oral drugs	dacslqxpzg(yulhylqopt) = Self- reported hypoglycemia episodes during the 6- day study period were highest among cohort D compared to the other three cohorts (p=0.01 vs. cohorts A & B; p=0.03 vs. cohort C) kvxrgwuvvi (qeyitbamxh )	Positive	17 Sep 2014
				Basal insulin + GLP-1 agonist
EASD2012	Not Applicable	Type 2 diabetes mellitus in obese	20	Metformin + insulin	hfscriapxy(wczzzvxoba) = only one patient reported about 5 hypoglycemias in the first month, when he tried to reach FPG below 6 mmol/L jxnqiskigf (peahexvzni ) View more	Positive	02 Oct 2012

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