A Study of IBI362 in Participants With Obesity or Overweight

Phase 3 Completed 610 enrolled Innovent Biologics (Suzhou) Co. Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Timeline

Start: 2022-11-14
Primary completion: 2023-08-21
Completion: 2024-04-16

Outcome

Met primary endpoint

paper and 73.9%, 82.0%, and 10.5% of the participants, respectively, had a weight reduction of at least 5% (P<0.001 for all comparisons with placebo). PMID 40421736 ↗

release “The GLORY-1 study met both primary endpoints– mazdutide 4 mg and 6 mg showed superiority to placebo” innoventbio.com ↗

release “Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints” innoventbio.com ↗

Publications

Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mazdutide	Protein / enzyme biologic	4 mg	Subcutaneous
Subject	Mazdutide	Protein / enzyme biologic	6 mg	Subcutaneous