Once-monthly bofanglutide held weight in Phase IIIb

Gan & Lee Pharmaceuticals said on November 4, 2026, that once-monthly bofanglutide injection maintained body weight over 24 weeks in GRADUAL-3, a Phase IIIb maintenance study in Chinese adults with obesity or overweight. The announcement is a company press release distributed on PR Newswire and mirrored by AAP News. The results are company-reported topline figures, not a peer-reviewed paper.

Bofanglutide is an investigational glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Gan & Lee. It is not an FDA-approved medicine.

What GRADUAL-3 tested

According to the release, GRADUAL-3 took people who finished 52 weeks of every-two-weeks bofanglutide in GRADUAL-1 and still met entry criteria. Randomization followed each person’s last study dose — the release’s “24 mg” or “48 mg” — into monthly bofanglutide or monthly placebo for another 24 weeks.

The company said the main outcome was how much body weight changed, as a percentage of baseline, by the end of that 24-week maintenance stretch.

Gan & Lee’s November 2025 study-initiation notice on ganlee.com described GRADUAL-3 as a 24-week Phase 3 study of once-monthly dosing after the GRADUAL program’s every-two-weeks work, with percentage change from baseline in body weight at week 24 among the primary endpoints. That earlier notice matches the design summarized in today’s topline release.

Company-reported weight results

After 24 weeks, Gan & Lee said mean percentage changes in body weight from baseline were 0.41% in the “24 mg” once-monthly group and -0.12% in the “48 mg” once-monthly group, compared with 8.52% in the placebo group (both p under 0.0001).

Read the signs carefully. The active arms were essentially flat versus the maintenance baseline (a small gain of 0.41% at the lower dose and a small loss of -0.12% at the higher dose). The placebo arm moved 8.52% in the direction the release treats as regain: the company says transitioning to once-monthly administration can “effectively prevent weight regain following discontinuation of the intensive treatment regimen.” Amino Wire is reporting the company’s own framing of that 8.52% comparator, not an independent re-analysis of patient-level data.

Gan & Lee also said once-monthly treatment maintained improvements in waist circumference, blood pressure and lipid levels.

Safety, as the company described it

The release said bofanglutide showed a favorable safety and tolerability profile across dose groups, with no new safety signals identified. The most common adverse events were gastrointestinal, and most of those were mild to moderate and transient, the company said. Those statements are Gan & Lee’s characterization of its own trial, not a regulator’s finding.

The “first” claim

Gan & Lee called GRADUAL-3 “the first completed Phase IIIb sequential study globally to evaluate the maintenance of weight-loss efficacy with once-monthly administration using a randomized controlled trial (RCT) design.” That is the company’s claim. Amino Wire has not audited every prior maintenance trial of every once-monthly GLP-1 candidate to independently confirm a global first.

What is not known

• Peer review. Detailed results are promised for future conferences and journals. Until then, the numbers exist only in company materials.
• How “baseline” was set. The release says percentage change from baseline after 24 weeks. It does not publish a table that separately labels randomization-day weight versus GRADUAL-1 week-52 weight for each arm. The regain framing is the company’s.
• Regulatory path outside China. The release does not announce FDA or other ex-China approvals for once-monthly bofanglutide.
• How these results compare with other weekly or monthly GLP-1 maintenance strategies. The press release does not include a head-to-head versus another marketed maintenance regimen.

This story summarizes a company press release. It is not medical advice.