At a glance
| Development codes | IBI362; LY3305677 |
|---|---|
| Targets | GLP-1 and glucagon receptors |
| Route | Subcutaneous injection |
| Approved jurisdiction | China |
| U.S. status | No FDA approval identified |
Overview
Developed as IBI362 and LY3305677, mazdutide combines appetite-related incretin signaling with glucagon receptor activity. Innovent announced China’s first approval for weight management in June 2025 and a subsequent type 2 diabetes approval that year. The GLORY-1 obesity trial enrolled Chinese adults using locally relevant BMI thresholds. That population and regulatory context matter when interpreting the results internationally. This catalog records the medicine as approved in its actual jurisdiction, while preserving the distinction between an NMPA-authorized product and an unapproved import or research preparation elsewhere.
How it works
GLP-1 receptor activation supports glucose-dependent insulin secretion, reduced food intake and other metabolic effects. Glucagon receptor activation adds effects on hepatic metabolism and energy expenditure, with the combined molecule designed to balance glucose and weight responses. The two targets distinguish mazdutide from GLP-1-only medicines and from GIP/GLP-1 agonists. Target count alone does not establish comparative effectiveness or safety.
Chinese approval scope
Innovent’s official announcements document NMPA approval for chronic weight management in June 2025 and for type 2 diabetes later in 2025. These authorizations concern regulated products and locally defined eligibility.
GLORY-1 trial
The phase 3 study randomized 610 Chinese adults with obesity or qualifying overweight. At forty-eight weeks, the higher trial group had a mean weight change of −14.01%, compared with +0.30% with placebo. The study also assessed cardiometabolic measures.
Supporting sources [3]
What the trial reported
Gastrointestinal adverse events were the most frequent and were mostly mild or moderate. Low discontinuation rates in this particular trial do not eliminate uncommon risks or show that tolerability will match in every clinical population.
Supporting sources [3]
Population and endpoint boundaries
The trial’s BMI thresholds, baseline characteristics and background care differ from many North American or European obesity trials. Indirect percentage comparisons do not establish superiority. Weight and risk-factor changes also do not substitute for a completed cardiovascular-outcomes study.
Supporting sources [3]
Why approval location matters
A medicine can be approved in China while remaining unapproved by the FDA. The applicable product information, manufacturing source and prescribing rules follow the jurisdiction, and foreign approval does not validate an online seller’s version of the ingredient.
Common questions
Is mazdutide approved everywhere? No. The cited approvals are in China; they do not authorize marketing in the United States.
Does the Chinese obesity trial establish the same response in every population? No. GLORY-1 provides direct evidence in its enrolled Chinese population, while generalization to other groups, clinical settings and long-term outcomes requires additional evidence.
Reading this profile
Jurisdiction: China — NMPA-approved for weight management and type 2 diabetes; no U.S. FDA approval identified as of 2026-10-27.. Molecular class: Dual GLP-1 and glucagon receptor agonist peptide.
This profile was written with AI-assisted research and checked against the linked sources. It has not been represented as a clinician’s review. Evidence summaries describe the cited studies and products; they do not establish that a separately purchased preparation is equivalent.
Sources & references
Follow the original material. Product labels define specific formulations and uses; trial registration describes a study and does not by itself establish benefit.
- Innovent: NMPA approval of mazdutide for weight management ↗Manufacturer / sponsor · Checked 2026-10-27
- Innovent: 2025 update confirming weight-management and diabetes approvals ↗Manufacturer / sponsor · Checked 2026-10-27
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. ↗Original research · Checked 2026-10-27