Mazdutide (LY3305677)
Once-weekly GLP-1 and glucagon receptor dual agonist (LY3305677 / IBI362). Approved by China's NMPA in June 2025 for chronic weight management; not approved by the US FDA.
60-Second Scientific Briefing
Mazdutide is a once-weekly injectable peptide that activates two receptors, GLP-1 and glucagon. It was developed by Eli Lilly (LY3305677) and by Innovent Biologics in China (IBI362), and China's regulator approved it in June 2025 for chronic weight management. It is not approved by the US FDA. In the GLORY-1 phase 3 trial (NEJM 2025, 610 Chinese adults), mean weight change at 48 weeks was −11.0% and −14.0% with 4 mg and 6 mg, against +0.3% with placebo.
What is Mazdutide?
Pharmacological Classification & Molecular IdentityMazdutide is a once-weekly injectable peptide that activates both the GLP-1 receptor and the glucagon receptor. It was developed by Eli Lilly (LY3305677) and, in China, by Innovent Biologics (IBI362). [1] N Engl J Med, 2025 ↗ [2] Innovent Biologics (company announcement), 2025 ↗
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingReceptor Selectivity: Agonist at the GLP-1 receptor and the glucagon receptor. GLP-1 receptor activation reduces appetite and improves glucose control; glucagon receptor activation is studied for its effects on energy expenditure and liver fat. [1] N Engl J Med, 2025 ↗
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsNot approved by the US FDA. China's National Medical Products Administration (NMPA) approved mazdutide in June 2025 for chronic weight management in Chinese adults with overweight or obesity, mainly on the basis of the GLORY-1 phase 3 trial. [1] Innovent Biologics (company announcement), 2025 ↗
Mazdutide is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesGLORY-1 (NEJM 2025): phase 3, double-blind, placebo-controlled trial in China; 610 adults with a BMI of 28 or more, or 24 to under 28 with a weight-related condition, randomised 1:1:1 to mazdutide 4 mg, 6 mg or placebo once weekly for 48 weeks. Mean weight change at week 32 was −10.09% and −12.55% vs +0.45%; at week 48 it was −11.00% and −14.01% vs +0.30%. At 48 weeks, 35.7% and 49.5% vs 2.0% had lost at least 15%. All prespecified cardiometabolic measures improved with mazdutide. [1] N Engl J Med, 2025 ↗
Clinical Evidence
GLORY-1 (NEJM 2025): phase 3, double-blind, placebo-controlled trial in China; 610 adults with a BMI of 28 or more, or 24 to under 28 with a weight-related condition, randomised 1:1:1 to mazdutide 4 mg, 6 mg or placebo once weekly for 48 weeks. Mean weight change at week 32 was −10.09% and −12.55% vs +0.45%; at week 48 it was −11.00% and −14.01% vs +0.30%. At 48 weeks, 35.7% and 49.5% vs 2.0% had lost at least 15%. All prespecified cardiometabolic measures improved with mazdutide.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesIn GLORY-1 the most frequent adverse events were gastrointestinal and mostly mild to moderate. Adverse events led to stopping treatment in 1.5% (4 mg), 0.5% (6 mg) and 1.0% (placebo). [1] N Engl J Med, 2025 ↗
The phase 3 data come from Chinese adults over 48 weeks. Long-term safety, cardiovascular outcomes and results in other populations have not been published. [1] N Engl J Med, 2025 ↗
Dose Approval Status
Commercial Dosing Status and Policy DirectivesApproved in China only; the approved dosing is set out in the Chinese prescribing information, which this monograph does not reproduce. GLORY-1 used once-weekly doses of 4 mg and 6 mg. There is no US-approved dose. Dosing is set by the prescriber. [1] N Engl J Med, 2025 ↗
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Mazdutide is a once-weekly injectable peptide that activates both the GLP-1 receptor and the glucagon receptor. It was developed by Eli Lilly (LY3305677) and, in China, by Innovent Biologics (IBI362).
- Targets & Selectivity: Agonist at the GLP-1 receptor and the glucagon receptor. GLP-1 receptor activation reduces appetite and improves glucose control; glucagon receptor activation is studied for its effects on energy expenditure and liver fat.
- GLORY-1 (NEJM 2025): phase 3, double-blind, placebo-controlled trial in China; 610 adults with a BMI of 28 or more, or 24 to under 28 with a weight-related condition, randomised 1:1:1 to mazdutide 4 mg, 6 mg or placebo once weekly for 48 weeks. Mean weight change at week 32 was −10.09% and −12.55% vs +0.45%; at week 48 it was −11.00% and −14.01% vs +0.30%. At 48 weeks, 35.7% and 49.5% vs 2.0% had lost at least 15%. All prespecified cardiometabolic measures improved with mazdutide.
- Safety considerations: In GLORY-1 the most frequent adverse events were gastrointestinal and mostly mild to moderate. Adverse events led to stopping treatment in 1.5% (4 mg), 0.5% (6 mg) and 1.0% (placebo).
? Unknown / Under Ongoing Investigation
- The phase 3 data come from Chinese adults over 48 weeks. Long-term safety, cardiovascular outcomes and results in other populations have not been published.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysMazdutide is a once-weekly injectable peptide that activates the GLP-1 and glucagon receptors. It was developed by Eli Lilly (LY3305677) and Innovent Biologics (IBI362), and was approved in China in June 2025 for chronic weight management.
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
- Mazdutide, first dual GCG/GLP-1 receptor agonist, receives approval from China's NMPA for chronic weight management (Innovent Biologics (company announcement), 2025-06-27)
It is an agonist at two receptors: GLP-1, which reduces appetite and improves glucose control, and glucagon, whose activation is studied for effects on energy expenditure and liver fat.
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
No. It is not approved by the US FDA. China's NMPA approved it in June 2025 for chronic weight management in Chinese adults with overweight or obesity.
- Mazdutide, first dual GCG/GLP-1 receptor agonist, receives approval from China's NMPA for chronic weight management (Innovent Biologics (company announcement), 2025-06-27)
GLORY-1 (NEJM 2025): 610 Chinese adults, once-weekly mazdutide 4 mg or 6 mg or placebo for 48 weeks. Mean weight change at 48 weeks was −11.0% and −14.0% vs +0.3% with placebo.
GLORY-1 was a phase 3, double-blind, placebo-controlled trial in China. Adults aged 18 to 75 with a BMI of at least 28, or 24 to under 28 with at least one weight-related condition, were randomised 1:1:1 to mazdutide 4 mg, mazdutide 6 mg or placebo once weekly for 48 weeks. At week 32 (primary end point) mean weight change was −10.09%, −12.55% and +0.45%, and 73.9%, 82.0% and 10.5% had lost at least 5%. At week 48 mean weight change was −11.00%, −14.01% and +0.30%, and 35.7%, 49.5% and 2.0% had lost at least 15%. All prespecified cardiometabolic measures improved with mazdutide.
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
In GLORY-1 the most frequent adverse events were gastrointestinal and mostly mild to moderate. Adverse events led to stopping treatment in 1.5% (4 mg), 0.5% (6 mg) and 1.0% (placebo).
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
The phase 3 data cover Chinese adults over 48 weeks. Long-term safety, cardiovascular outcomes and results in other populations have not been published.
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
Approved in China only, with dosing set out in the Chinese prescribing information. GLORY-1 used once-weekly 4 mg and 6 mg. There is no US-approved dose; dosing is set by the prescriber.
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
Storage conditions are set in the approved Chinese product information. There is no US label.
Mazdutide is not named on the 2026 WADA Prohibited List, and it holds a government approval in China, so section S0 (non-approved substances) does not apply. Athletes should confirm with their national anti-doping organisation.
- WADA Prohibited List (World Anti-Doping Agency)
Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) (N Engl J Med, 2025-06-12)
- Mazdutide, first dual GCG/GLP-1 receptor agonist, receives approval from China's NMPA for chronic weight management (Innovent Biologics (company announcement), 2025-06-27)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and published studiesOnce-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) ↗
https://pubmed.ncbi.nlm.nih.gov/40421736/
Mazdutide, first dual GCG/GLP-1 receptor agonist, receives approval from China's NMPA for chronic weight management ↗
https://www.biospace.com/press-releases/innovent-announces-mazdutide-first-dual-gcg-glp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management