Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Authors' conclusion
In Chinese patients with type 2 diabetes, mazdutide dosed up to 6 mg was generally safe and demonstrated clinically meaningful HbA1c and body weight reductions.
Study context
- Population
- Chinese adults with T2D inadequately controlled with diet and exercise alone or with stable metformin (HbA1c 7.0–10.5% [53–91 mmol/mol])
- Participants
- 51 / 49 / 49 / 50 / 51
- Comparison
- Mazdutide 3, 4.5 or 6 mg vs open-label dulaglutide 1.5 mg vs placebo, once weekly SC for 20 weeks
- Mazdutide 3 mgn = 51
- Mazdutide 4.5 mgn = 49
- Mazdutide 6 mgn = 49
- Dulaglutide 1.5 mgn = 50
- Placebon = 51reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 20
Methodological detailsdouble-blind, placebo-controlled, phase 2
- Double-blind
- Placebo-controlled
- Phase 2
Primary result
As reported in the abstract
Mean change in HbA1c · baseline to week 20
Dulaglutide 1.5 mg
−1.35%
mean
Placebo
0.03%
mean
Mazdutide 3 mg vs Placebo: P < 0.0001 vs. placebo · Mazdutide 4.5 mg vs Placebo: P < 0.0001 vs. placebo · Mazdutide 6 mg vs Placebo: P < 0.0001 vs. placebo · Dulaglutide 1.5 mg vs Placebo: P < 0.0001 vs. placebo
- Mean HbA1c change range across mazdutide doses
- −1.41% to −1.67%
Further findings
Mean
| Outcome | Dulaglutide 1.5 mg | Placebo |
|---|---|---|
| Mean percent change in body weight · baseline to week 20 | −2.7% | −1.4% |
- Mean percent change in body weight — Dose-dependent weight change with mazdutide, up to
- −7.1%
HbA1c targets <7.0% and ≤6.5%; weight loss ≥5% and ≥10% · week 20
- Mazdutide recipients more likely than placebo to achieve these targets
Safety
| Outcome | Values |
|---|---|
| Most common AEs with mazdutide | Placebo 8% · hypoglycemia 8% |
- Most common AEs with mazdutide — Diarrhea (mazdutide)
- 36%
- Most common AEs with mazdutide — Decreased appetite (mazdutide)
- 29%
- Most common AEs with mazdutide — Nausea (mazdutide)
- 23%
- Most common AEs with mazdutide — Vomiting (mazdutide)
- 14%
- Most common AEs with mazdutide — Hypoglycemia (mazdutide)
- 10%
Original publication
Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Diabetes Care. Published 9 November 2023. doi:10.
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