Obesity evidence dossier
BGM0504
Late-stage China program with sponsor-reported 52-week efficacy comparable to leading incretin therapies; not yet an approved medicine.
Total weight loss
19.2%
BGM0504-III-WL · 15 mg weekly · week 52 · Analysis not fully specified
Placebo-adjusted
16.1%
Difference from placebo in the same study when reported.
Study context
Dual GLP-1 receptor/GIP receptor agonist peptide./Adults with obesity or overweight in China; diabetes exclusion not specified in this source/652 participants across the study/52-week endpoint
Baseline: See the source for enrollment criteria
Ranked result & calculation
BGM0504-III-WL · 15 mg weekly · 52 weeks
Adults with obesity or overweight in China; diabetes exclusion not specified in this source. 652 participants across the study (not this dose arm alone).
Analysis not fully specified. The source does not establish a treatment-policy analysis; interpret this score provisionally. Primary analysis; the separate per-protocol figure is 19.3%. Formal estimand not specified.
- Average weight loss
- 19.2%
- Placebo group
- 3.1% loss
- Beyond placebo
- 16.1 percentage points (arm subtraction)
- Stopped due to adverse events
- Not verified for this result
Score: 70% × 78.8 total-loss points + 30% × 76.0 beyond-placebo points = 78/100, rounded. Conversion scales
BrightGene, Phase 3 primary analysis ↗Phase 3 · Sponsor disclosure · Reviewed 2026-09-21
Evidence
Benchmark read
BGM0504-III-WL: Analysis not fully specified. Primary analysis; the separate per-protocol figure is 19.3%. Formal estimand not specified.
Safety
Side effects and cautions
Discontinuation read
Adverse-event discontinuation has not been verified for this result.
Common side effects
Sponsor reported generally favorable tolerability; treatment discontinuation due to adverse events at 52 weeks was 1.7%, 1.2%, and 0.7% for 5, 10, and 15 mg, respectively.
Main cautions
Investigational outside any future approved label; full adverse-event tables and long-term outcomes are not established by the topline release.
Upcoming catalyst
What to watch next
Regulatory review of the accepted China weight-management NDA and further Phase 3 readouts.
Linked clinical trials
Trials in the saddl3 obesity snapshot
Non-diabetic obesity studies are prioritized; diabetes and healthy-volunteer studies remain visible and labeled.
NCT06704581
Phase 3
A Study of BGM0504 Injection in Participants with Obesity or Overweight
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Non-diabetic obesity
Nov 26, 2024
NCT06911203
Phase 2
A Study of BGM0504 in Participants With Obesity
BrightGene Bio-Medical Technology Co., Ltd.
Non-diabetic obesity
Oct 28, 2025
NCT06973681
Phase 2
A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
BrightGene Bio-Medical Technology Co., Ltd.
Non-diabetic obesity
May 15, 2025
NCT06920056
Phase 1
A Study of BGM0504 in Overweight or Obese Participants
BrightGene Bio-Medical Technology Co., Ltd.
Non-diabetic obesity
Sep 9, 2025
NCT07239973
Phase 1
A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects
BrightGene Bio-Medical Technology Co., Ltd.
Healthy volunteer
Nov 20, 2025
NCT07166081
Phase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
BrightGene Bio-Medical Technology Co., Ltd.
Type 2 diabetes / obesity
Sep 19, 2025
NCT06929156
Phase 1
A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function
BrightGene Bio-Medical Technology Co., Ltd.
Healthy volunteer
Feb 11, 2026
NCT06714955
Phase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects
BrightGene Bio-Medical Technology Co., Ltd.
Type 2 diabetes / obesity
Sep 22, 2025