Obesity evidence dossier

Bofanglutide

Investigational extended-interval injectable GLP-1RA with substantial Phase 2b weight-loss evidence; confirmatory Phase 3 obesity evidence is pending.

Gan & Lee Pharmaceuticals; Carnot Laboratories is the Latin American Phase 3 sponsorPhase 3: BALANCE-OBS (NCT07622810), not yet recruiting in Latin American adults with overweight or obesity.Subcutaneous injection; studied once weekly and once every two weeks.
Weight loss score /10078
Comparison statusOther trial data · Analysis not fully specified
EvidencePhase 3 · Sponsor disclosure
Follow-up52 weeks

Total weight loss

18.5%

GRADUAL-1 · 48 mg every two weeks · week 52 · Analysis not fully specified

Placebo-adjusted

17.4%

Difference from placebo in the same study when reported.

Study context

Long-acting human GLP-1 receptor agonist with a 22-carbon fatty-diacid moiety./Adults with obesity or overweight in China; diabetes exclusion not specified in this source/640 participants across the study/52-week endpoint

Baseline: See the source for enrollment criteria

Ranked result & calculation

GRADUAL-1 · 48 mg every two weeks · 52 weeks

Adults with obesity or overweight in China; diabetes exclusion not specified in this source. 640 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. Modified intention-to-treat analysis; discontinuation handling is not specified. Separate US per-protocol results are not used.

Average weight loss
18.54%
Placebo group
1.11% loss
Beyond placebo
17.43 percentage points (arm subtraction)
Stopped due to adverse events
Not verified for this result

Score: 70% × 76.2 total-loss points + 30% × 80.7 beyond-placebo points = 78/100, rounded. Conversion scales

Gan & Lee, GRADUAL-1 ↗Phase 3 · Sponsor disclosure · Reviewed 2026-09-21

Evidence

Benchmark read

GRADUAL-1: Analysis not fully specified. Modified intention-to-treat analysis; discontinuation handling is not specified. Separate US per-protocol results are not used.

Safety

Side effects and cautions

Discontinuation read

Adverse-event discontinuation has not been verified for this result.

Common side effects

Mostly grade 1–2 gastrointestinal adverse events, particularly nausea, vomiting, and diarrhea; injection-site reactions also occurred.

Main cautions

Not approved for weight management. High-dose groups had more treatment discontinuations, and Phase 2b evidence was limited to a Chinese population and 30 weeks.

Upcoming catalyst

What to watch next

BALANCE-OBS Phase 3 initiation and eventual 36-week comparative results.

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