Evaluation of the Safety, Efficacy and Pharmacokinetics of BGM0504 in Chinese Adults With Type 2 Diabetes: A Multicentre, Randomised, Controlled and Double‐Blind Phase II Trial
Primary result · Mean change in HbA1c from baselineResult — go to the resultTreatment difference (LSM) −1.82 to −2.56 %Authors' conclusion
BGM0504 shows a signal reduction for HbA1c, FPG, 2 h PG and body weight in Chinese adults with T2DM. The 12-week treatment with BGM0504 was safe and well-tolerated, with the 15 mg dose showing the most substantial effects.
Study context
- Population
- Chinese adults with T2D
- Participants
- 64 adults
- Comparison
- BGM0504 5, 10 or 15 mg vs placebo vs semaglutide 1 mg, once weekly
- BGM0504 5 mgn = 12
- BGM0504 10 mgn = 12
- BGM0504 15 mgn = 12
- Placebon = 12reference
- Semaglutide 1 mgn = 16
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 12
Methodological detailsmulticentre, double-blind, placebo-controlled, semaglutide-positive-controlled, phase II
- Multicentre
- Double-blind
- Placebo-controlled
- Semaglutide-positive-controlled
- Phase II
Primary result
Mean change in HbA1c from baseline
Treatment difference (LSM)
−1.82 to −2.56 %
all p < 0.05
Change by group
BGM0504 5 mg
−1.72
mean · %
BGM0504 10 mg
−1.94
mean · %
BGM0504 15 mg
−2.48
mean · %
Semaglutide 1 mg
−1.43
mean · %
Placebo
0.28
mean · %
As reported in the abstract
Secondary outcomes
| Outcome | P value |
|---|---|
| FPG, 2 h PG and body weightSignal for lowering FPG, 2 h PG and body weight | all p < 0.05 |
HbA1c < 6.5% or < 7.0%
- Proportion achieving HbA1c < 6.5% or < 7.0% increased in a dose-dependent manner
Fasting plasma glucose (FPG), 2 h PG and body weight
- 15 mg dose showed superior weight reduction to semaglutide
Pharmacokinetics
- Linear exposure-response relationship confirmed
Safety
- All doses well tolerated, with mostly mild adverse events
Original publication
Evaluation of the Safety, Efficacy and Pharmacokinetics of BGM0504 in Chinese Adults With Type 2 Diabetes: A Multicentre, Randomised, Controlled and Double‐Blind Phase II Trial. Diabetes Obes Metab. Published 31 May 2026. doi:10.
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