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Mazdutide Efficacy & Safety

Mazdutide (also known as IBI362 or LY-3305677) is a dual agonist of the GLP-1 (glucagon-like peptide-1) receptor and the glucagon receptor.

Thus, it seeks to combine appetite suppression with increased energy expenditure for enhanced metabolic benefits.

Additionally, it’s administered once-weekly via subcutaneous injection.

Moreover, Development & Regulatory Milestones

• Development
  Moreover, the drug is developed by Eli Lilly, with Innovent Biologics holding the rights in China under a licensing agreement.

• As a result, China granted regulatory approval in June 2025, enabling mazdutide as the first dual GLP-1/glucagon receptor agonist.
  Furthermore, in June 2025, China’s NMPA approved mazdutide for overweight adults, becoming the first dual GLP-1/glucagon receptor agonist.

  • The approval was driven by data from the GLORY-1 Phase III trial, which showed significant weight reductions at 32 and 48 weeks.

Clinical Efficacy & Safety

• Phase I / Phase II Trials
  Early trials found that mazdutide was well tolerated, with dose-dependent weight loss and a side effect profile similar to other GLP-1 agonists.

• Common side effects included nausea, diarrhea, and upper respiratory infections

• Phase II (24 Weeks)
  In a randomized controlled trial among Chinese adults with overweight or obesity:

  • Weight loss ranged from –6.7% at 3 mg up to –11.3% at 6 mg, compared to a +1.0% increase in placebo.

  • A significant proportion achieved ≥5% and ≥10% weight loss; improvements were also seen in BMI, waist circumference, blood pressure, lipids, HbA1c, liver enzymes, and inflammatory markers

• Phase III (GLORY-1, up to 48 Weeks)

  • At 48 weeks:

    Mean weight reduction: –12.0% (4 mg), –14.8% (6 mg), vs –0.5% for placebo.

  • ≥5% weight loss: 73.5% (4 mg), 82.8% (6 mg), vs 11.5%.
  • ≥15% weight loss: 37.0% (4 mg), 50.6% (6 mg), vs 2.1%.

    • Liver fat dropped dramatically—–65.9% (4 mg) and –80.2% (6 mg) in patients starting with ≥10% liver fat.

Attribute Details

Mechanism Dual GLP-1 and glucagon receptor agonist

Administration Once-weekly injection

Developer Eli Lilly (global), Innovent (China)

Approved Yes, in China (June 2025) for chronic weight management

Efficacy12–15% weight loss over 48 weeks (Phase III), metabolic improvements

Safety Well-tolerated; common GI and mild side effects.

Final Thoughts

Mazdutide marks a significant advancement in obesity pharmacotherapy, combining dual receptor agonism for enhanced weight and metabolic control.

Now approved in China, it’s backed by robust Phase II and III data showing substantial weight loss (up to nearly 15%) and reductions in liver fat.

We can expect further developments in the coming months, especially regarding broader regulatory submissions and potential approvals in other regions.