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Mazdutide

IBI362 · LY3305677 · Mazdutide

C
Animal replicated
RouteInjectableGray-market only
C
Evidence grade: Animal replicated

Effect demonstrated in multiple animal studies; human data sparse or extrapolated. Grades summarize evidence quality, not whether a compound is appropriate, legal, or risk-free.

At a glance
What it is
IBI362 / LY3305677 — Dual GLP-1R / GCGR Agonist — Innovent Biologics / Eli Lilly Origin — GLP-1/Glucagon Dual Agonist, Oxyntomodulin Analog, Peptide.
Why people use it
Used primarily for weight loss and gut health.
If you only read one thing

Mazdutide is the world's first approved dual GCG/GLP-1 receptor agonist — a regulatory milestone that occurred in the world's most populous country in June 2025. It has Phase 3 data in tens of thousands of Chinese patients, NMPA approval for obesity and T2D, and publication in Nature. And virtually no one in the Western medical establishment is paying attention to it. The compound that is simultaneously approved and obscure reflects a broader reality: the pharmaceutical regulatory universe is jurisdictionally fragmented in ways that create information asymmetries. NMPA approval is a rigorous national regulatory evaluation — not equivalent to FDA approval, but not nothing. For community members in Western countries: mazdutide is a research chemical without FDA review, accessed without physician oversight, using quality-unverified research vendor products, for an indication where approved alternatives (semaglutide, tirzepatide) exist with FDA-reviewed safety and efficacy data. The NMPA approval changes the risk framing somewhat versus a purely preclinical compound — but does not substitute for the individual-level oversight that physician prescription provides.

Published literature
5human RCTs0human studies1animal0in vitro

Counts summarize published/registration-quality Phase 2 and Phase 3 obesity/T2D/MASH controlled human studies; NMPA approval is route-scoped to subcutaneous mazdutide, not topical use.

Evidence reality check
Human evidence
5 human studies
5 randomized; 0 observational.
Preclinical base
1 lab signal
1 animal; 0 in-vitro/mechanistic.
Risk posture
No major flags listed
Review route-specific cautions before use.
Properties
✓ Human RCT
Evidence
CAnimal replicated
The Approval Timeline
June 27, 2025: NMPA approval for chronic weight management in Chinese adults with overweight or obesity — world's first approved GCG/GLP-1 dual agonist. September 2025: NMPA approval for glycemic control in adults with T2D. Phase 3 obesity trial (GLORY-1): met all primary and key secondary endpoints; results reported in 2024. Phase 3 T2D trials (DREAMS-1, DREAMS-2): published back-to-back in Nature as Accelerated Article Previews, December 2025; superior to dulaglutide for both glucose lowering and weight reduction. Fierce Pharma named mazdutide one of the top 10 most anticipated drugs globally in 2025.
The Eli Lilly Origin
Mazdutide originated as LY3305677 in Eli Lilly's GLP-1/glucagon co-agonist research program — the same program that produced other GCGR-containing compounds at Lilly. Eli Lilly licensed the compound to Innovent Biologics for development and commercialization exclusively in China. Innovent conducted the entire clinical development program in Chinese adults. The compound Lilly kept for its own global program — with the GCGR axis adding the hepatic fat mechanism — became what Boehringer Ingelheim independently developed as survodutide. The two companies pursued different structural approaches to the same dual GLP-1R/GCGR mechanism.
Phase 3 Data Highlights
GLORY-1 (obesity, Chinese adults): at weeks 32 and 48, significant body weight reduction from baseline; all primary and key secondary endpoints met. Improvements in waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content, and insulin sensitivity. DREAMS-1 and DREAMS-2 (T2D, Chinese adults): Phase 3 results published in Nature December 2025; mazdutide demonstrated better efficacy than dulaglutide (a standard GLP-1 agonist) for both glycemic control and weight reduction. Favorable safety profile consistent with GLP-1 class.
Community Access and Status
Mazdutide occupies a unique regulatory position: it is an NMPA-approved pharmaceutical in China (available by prescription), a research chemical in Western markets (no FDA/EMA approval), and increasingly available on gray-market and research chemical vendor sites globally. Community users in the West are self-administering a compound that is simultaneously approved for human use in the world's largest market and unapproved in their own jurisdiction. This creates a different risk framing from most research chemicals — the safety and efficacy profile has been evaluated by a national regulatory authority.
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