mazdutide (LY3305677) / Eli Lilly, Innovent Biologics - LARVOL DELTA

Effect of Mazdutide on MASH Fibrosis—Targeting the Liver–Gut Axis and Microbiome (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol)

A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) (clinicaltrials.gov) - P2 | N=165 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Mazdutide vs. Placebo as Monotherapy in Patients with Type 2 Diabetes (DREAMS-1) (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Monotherapy • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Mazdutide, a Dual GLP-1R/GCGR Agonist, Reduces Hyperuricemia by Modulating Energy and Lipid Metabolism and Inhibiting Hepatic Purine Metabolism (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Metabolic Disorders

The Dual Glucagon and Glucagon-Like Peptide 1 Receptor Agonist Mazdutide Outbalanced Glucagon-Like Peptide 1 Receptor Agonist Semaglutide Monotherapy in Improving Mice Liver Fat Accumulation (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Monotherapy • Preclinical • Metabolic Disorders

GLORY-OSA: A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2 (clinicaltrials.gov) - P3 | N=260 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD） (clinicaltrials.gov) - P3 | N=470 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities. (PubMed, Peptides) - "Recent studies with peptide-based incretin herapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP)...New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The..."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Obstructive Sleep Apnea • Orthopedics • Renal Disease • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Sep 2025 | Trial primary completion date: Feb 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study of IBI362 in Subjects with HFpEF or HFmrEF Combined with Obesity (clinicaltrials.gov) - P2 | N=141 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Obesity

Comparative efficacy of incretin drugs on glycemic control, body weight, and blood pressure in adults with overweight or obesity and with/without type 2 diabetes: a systematic review and network meta-analysis. (PubMed, Front Endocrinol (Lausanne)) - "Retatrutide (mean difference (MD): -11.91 kg, 95% CI: -19.00 to -4.82, P-score: 0.80, p: 0.0003) and Tirzepatide (MD: -12.78 kg, 95% CI: -16.10 to -9.46, P-score: 0.89, p < 0.0001) exhibited superior efficacy in reducing body weight, with all other agents except Mazdutide (MD: -5.31 kg, 95% CI: -9.78 to -0.84, P-score: 0.37, p: 0.0189) achieving reductions of over 8 kg. Multi-receptor drugs demonstrated substantial therapeutic potential in weight management, glycemic control, and blood pressure regulation in adults with overweight or obesity, with or without diabetes, with a generally favorable safety profile. https://www.crd.york.ac.uk/prospero/, identifier CRD42024554005."

Clinical • Journal • Retrospective data • Review • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Emerging pharmacotherapies for obesity: A systematic review. (PubMed, Pharmacol Rev) - "Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, and TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide and survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate...This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives."

Journal • Review • Genetic Disorders • Obesity

A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Addiction (Opioid and Alcohol)

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=179 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

DREAMS-3: A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity (clinicaltrials.gov) - P3 | N=349 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Jun 2026 | Trial primary completion date: May 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Approved and Emerging Hormone-Based Anti-Obesity Medications: A Review Article. (PubMed, Indian J Endocrinol Metab) - "Two GLP1RAs, namely Liraglutide and Semaglutide, have been approved by the Food and Drug Administration (FDA) and European Medicine Agency (EMA) for use in clinical practice for weight loss. Three oral GLP1RAs, namely Semaglutide, Danuglipron, and Orforglipron, are undergoing advanced clinical trials in individuals with obesity. Amylin receptor agonist (AMYRA) Cagrilintide, when used alone or in combination with Semaglutide, has demonstrated substantial weight reduction in clinical trials. Tirzepatide, a dual agonist for the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, has been observed to be associated with a significant placebo-subtracted weight reduction of 17.8% in a 72-week randomized controlled trial...Three long-acting GLP1R/glucagon receptor (GCGR) dual agonists, namely Survodutide, Mazdutide, and Pemvidutide, exhibited significant weight loss in clinical trials. Retatrutide, a GLP1R/GCGR/GIPR tri-agonist, has been associated with a..."

Journal • Review • Cardiovascular • Genetic Disorders • Obesity

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=1040 | Recruiting | Sponsor: Eli Lilly and Company | N=765 ➔ 1040

Enrollment change • Genetic Disorders • Obesity

Glucagon-like Peptide-1 Receptor Agonists for Adult Obesity: Where Next? (ISPOR-EU 2024) - "The most commonly assessed GLP-1 RAs were liraglutide and semaglutide (48%), followed by exenatide (24%) and dulaglutide (21%). Other less commonly identified agents included danuglipron, cotadutide, taspoglutide and mazdutide (2% each)... This research highlights growing interest and evidence in GLP-1 RAs for obesity management. Further research is needed to continue evaluating the long-term efficacy and safety of these interventions."

Clinical • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Polycystic Ovary Syndrome • Type 2 Diabetes Mellitus

Efficacy of Mazdutide for Treating PCOS (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Shanghai Zhongshan Hospital | Initiation date: Jul 2024 ➔ Oct 2024

Trial initiation date • Polycystic Ovary Syndrome

Seven glucagon-like peptide-1 receptor agonists and polyagonists for weight loss in patients with obesity or overweight: an updated systematic review and network meta-analysis of randomized controlled trials. (PubMed, Metabolism) - "Retatrutide (both doses) and tirzepatide exhibited superior efficacy compared to other GLP-1 receptor agonists and polyagonists in reducing body weight and waist circumference. Patients without T2DM, those with a high BMI, and individuals undergoing longer treatment cycles demonstrated significantly greater weight loss and reductions in waist circumference. Dual or triple receptor agonists (GLP-1 plus glucose-dependent insulinotropic polypeptide and/or Glucagon receptor) are more effective for weight loss than GLP-1 receptor agonists."

Journal • Retrospective data • Review • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Emerging Pharmacotherapies for Obesity: A Systematic Review. (PubMed, Pharmacol Rev) - "Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide, survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate...This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives."

Journal • Review • Developmental Disorders • Genetic Disorders • Obesity

Mazdutide Versus Dulaglutide for Weight Loss and Diabetes Management: Meta-Analysis of Randomized Clinical Trials. (PubMed, Am J Ther) - No abstract available

Clinical • Journal • Retrospective data • Diabetes • Metabolic Disorders

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P2 | N=765 | Recruiting | Sponsor: Eli Lilly and Company | N=390 ➔ 765 | Trial completion date: Sep 2025 ➔ Aug 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity