Mazdutide
GLP-1 / glucagon receptor dual agonist
Also known as: IBI362, LY3305677, mazdutide, oxyntomodulin analog
Evidence level: Clinical research
What it is
Mazdutide is a lab-made peptide best known for weight loss and blood-sugar control — it activates both the GLP-1 and glucagon receptors at once (a 'dual agonist'), with the glucagon component thought to add extra effects on energy expenditure and liver fat beyond GLP-1 alone. Given as a once-weekly injection, it is approved in China for weight management and type 2 diabetes, but it is investigational and not FDA-approved in the US.
What the research found
Mazdutide (a GLP-1/glucagon dual agonist) has been studied for weight loss and type 2 diabetes, largely in Chinese adults. In the Phase 3 GLORY obesity trials it was associated with reductions in body weight (in GLORY-2, a −16.65% mean change on versus −1.50% on placebo over 60 weeks), and in the Phase 3 DREAMS diabetes trials it was associated with reductions in HbA1c and body weight. Reported trial side effects include gastrointestinal symptoms and increased heart rate; specifics will shift as data matures. The research attributes these weight and blood-sugar changes largely to reduced appetite and food intake (greater satiety via the gut-hormone pathway these agents act on), an appetite and energy-intake mechanism measured across the trials.
Status and regulatory position
⚠️ investigational (US) — not FDA-approved. Mazdutide (IBI362 / LY3305677, Innovent Biologics, licensed from Eli Lilly) is NMPA-approved in China — chronic weight management (June 2025; the first GLP-1/glucagon dual agonist approved for weight loss) and glycemic control in adults with type 2 diabetes (September 2025) — via the GLORY (obesity) and DREAMS (type 2 diabetes) Phase 3 programs. It is not FDA-approved in the US (not FDA-submitted as of April 2026; Eli Lilly holds ex-China rights) and remains investigational / research-supply in the US. Once-weekly SubQ. Not DEA-scheduled. GLP-1-class compounds are not currently on the WADA Prohibited List (consistent with the rest of the GLP-1 family — verify current edition before competition). Values below will shift as further data reports — re-verify before relying on specifics.
Safety
Mazdutide is investigational and not FDA-approved in the US; research- supply purity and identity are not guaranteed. It is not on the WADA Prohibited List. VialWise is a research and educational reference, not medical advice — consult a licensed professional.
Disclosures
⚠️ For research and educational purposes only. Mazdutide is not FDA-approved. Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions.
⚠️ Investigational in the US — specifics will change. Mazdutide is NMPA-approved in China (obesity + type 2 diabetes) but is not FDA-approved in the US and remains research-supply here. Doses, half-life, efficacy, and safety figures are from published trials and China labeling and will be refined as data matures. Treat every number here as a current-best-evidence snapshot, not a settled fact.
⚠️ Glucagon-receptor agonism adds mechanisms — and risks — beyond pure GLP-1. The glucagon arm can raise heart rate and affect hepatic glucose output. This is not just "a stronger GLP-1." Dual agonists have their own emerging safety profile distinct from semaglutide/tirzepatide.
Quick reference
| Compound class | GLP-1 receptor / glucagon receptor dual agonist (oxyntomodulin analog; injectable peptide) |
|---|---|
| Developer | Innovent Biologics (licensed from Eli Lilly) |
| Route / frequency | Subcutaneous, once weekly |
| Status (2026) | Approved in China (obesity, Jun 2025; T2D, Sep 2025) via the GLORY / DREAMS Phase 3 programs; not FDA-approved in the US |
| Key trial | Phase 3 obesity: GLORY-1 (N Engl J Med 2025[¹]), GLORY-2 (JAMA 2026[³]); Phase 3 T2D: DREAMS-1 / DREAMS-2 (Nature 2025[⁴][⁵]) |
| Half-life | Once-weekly dosing implies a multi-day half-life; a specific published human t½ is still maturing ⚠️ not pinned |
In depth
Mazdutide (IBI362 / LY3305677) is a GLP-1 receptor / glucagon receptor dual agonist and an oxyntomodulin analog — the next receptor-coverage step beyond the pure GLP-1 agonists, adding glucagon-receptor activity to GLP-1's appetite-suppression and glycemic effects. The glucagon arm is thought to add energy expenditure and hepatic-fat reduction. It is once-weekly and, while NMPA-approved in China, remains investigational in the US.
Development. Innovent Biologics, licensed from Eli Lilly; developed primarily in China. The GLORY (obesity) and DREAMS (type 2 diabetes) Phase 3 programs read out in Chinese adults: GLORY-1 on weight (NEJM 2025[¹]) and GLORY-2 (JAMA 2026[³]), and DREAMS-1 / DREAMS-2 on glycemic control (Nature 2025[⁴][⁵]). China's NMPA approved mazdutide for chronic weight management (June 2025) and for type 2 diabetes glycemic control (September 2025), but it is not FDA-approved in the US.
Where it sits in the library's GLP-1 family. Pure GLP-1: semaglutide, liraglutide, dulaglutide, exenatide. GLP-1/GIP: tirzepatide. GLP-1/glucagon dual: [survodutide.md](./survodutide.md) and mazdutide (this entry). GLP-1/GIP/glucagon triple: retatrutide. Mazdutide is one of the two GLP-1/glucagon dual-agonist rungs.
Regulatory status. NMPA-approved in China (chronic weight management, June 2025; type 2 diabetes glycemic control, September 2025); a supplementary application for moderate-to-severe obesity was accepted for NMPA review in November 2025. Investigational in the US; not FDA-approved (not FDA-submitted as of April 2026). Not DEA-scheduled. GLP-1-class compounds are not on the WADA 2026 Prohibited List (consistent with the rest of the family; verify current edition).
Reported side effects
Commonly reported
- GI: nausea, vomiting, diarrhea, decreased appetite (dose/titration-dependent — the class hallmark)
- Increased heart rate (the glucagon arm + GLP-1 class both contribute — notable for dual agonists)
- Injection-site reactions, fatigue, headache
Serious
- Acute pancreatitis (severe abdominal pain radiating to back) — GLP-1-class concern
- Gallbladder disease
- Sustained tachycardia / palpitations (watch given the glucagon-arm HR effect)
- Severe persistent GI symptoms → dehydration → acute kidney injury
- Medullary thyroid carcinoma signal is a GLP-1-class boxed-warning concern; dual-agonist long-term data are immature
Contraindications and warnings
Personal/family history of medullary thyroid carcinoma or MEN2 — GLP-1-class concern; carry the same caution pending dual-agonist-specific data.
History of pancreatitis — caution.
Cardiovascular caution — the glucagon arm's heart-rate effect warrants attention.
Other incretin agonists — do not co-administer.
Pregnancy/lactation — no adequate data; avoid.
Investigational status — unapproved in the US; research-supply purity/identity not guaranteed.
Regulatory: not FDA-approved (US); not DEA-scheduled; GLP-1 class not WADA-listed (verify current edition).
Key terms
- GLP-1 receptor agonist
- A compound that switches on the GLP-1 receptor, the same target a natural gut hormone uses to signal fullness and help regulate blood sugar.
- Glucagon receptor
- A receptor that, when activated, affects blood-sugar output by the liver and may increase energy expenditure.
- Dual agonist
- A compound that activates two different receptors at once (for example, the GLP-1 and glucagon receptors).
- Investigational
- Still being studied and not yet approved by regulators for general use.
- Subcutaneous
- An injection into the fatty layer just under the skin, rather than into a muscle or vein.
Sources
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. (2025). N Engl J Med, 392(22):2215–2225.(PMID 40421736 · NCT05607680)
- Mazdutide phase 1b (multiple-ascending-dose trial) — Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362)... EClinicalMedicine, 2022;54:101691.(PMID 36247927 · NCT04440345)
- GLORY-2 — Gao L, et al. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA, 2026;336(5):377–388.(PMID 42251595 · NCT06164873)
- DREAMS-1 — Zhu D, et al. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature, 2026;652(8108):174–180 (published online 17 Dec 2025).(PMID 41407859 · NCT05628311)
- DREAMS-2 — Guo L, et al. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature, 2026;652(8108):181–188 (published online 17 Dec 2025).(PMID 41407860 · NCT05606913)
- Mazdutide (phase 2) — Ji L, et al. Mazdutide in Chinese adults with a BMI ≥30 kg/m² but without diabetes: A phase 2 randomized controlled trial. Med, 2026;7(5):101063.(PMID 41875890)
- Meta-analysis (9 RCTs, N=2292) — Kamrul-Hasan ABM, et al. Efficacy and Safety of the Dual Glucagon-Like Peptide-1 and Glucagon Receptor Agonist Mazdutide in Predominantly Chinese Adults With Obesity and/or Type 2 Diabetes: A Systematic Review and Meta-Analysis. Diabetes Obesity and Metabolism, 2026;28(10):8777–8794.(PMID 42410325)
- Regulatory (China NMPA — corporate/regulatory sources, not peer-reviewed). Innovent Biologics: NMPA approval for chronic weight management (June 27, 2025 — the first GLP-1/glucagon dual agonist approved for weight loss) and for glycemic control in adults with type 2 diabetes (September 2025); a supplementary application (moderate-to-severe obesity) was accepted for NMPA review in November 2025. Per web reporting, mazdutide had not been submitted to the FDA as of April 2026. Sources: Innovent / PR Newswire approval press releases + Fierce Pharma coverage (flagged as corporate/regulatory, not peer-reviewed). WADA: GLP-1/glucagon class not on the 2026 Prohibited List per the pattern verified for the other GLP-1 entries (local archive); confirm current edition. Half-life: once-weekly dosing implies a multi-day human half-life, but a compound-specific published human t½ is still maturing — deliberately not pinned to a hard number here pending PK publication.
Related entries
- Amycretin — same mechanism class
- CagriSema — same mechanism class
- Dulaglutide — same mechanism class
- Exenatide — same mechanism class
- Liraglutide — same mechanism class
- Orforglipron — same mechanism class
Entry last updated 2026-09-03. Sourced from published literature and regulatory labelling; see Sources above.