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Gan & Lee Begins GRADUAL-3: A New Phase 3 Trial for Its Once-Monthly GLP-1 Bofanglutide

28 Nov 2025
Admin
News Article

Gan & Lee Begins GRADUAL-3: A New Phase 3 Trial for Its Once-Monthly GLP-1 Bofanglutide

Gan & Lee Pharmaceuticals has launched GRADUAL-3, its third large-scale Phase 3 study for bofanglutide, a next-generation GLP-1 receptor agonist for obesity and overweight.

This study explores a simple idea with huge potential: Can a once-monthly GLP-1 injection maintain weight loss and boost long-term adherence?

What GRADUAL-3 Will Test?g

GRADUAL-3 will evaluate the efficacy and safety of once-monthly bofanglutide over 24 weeks.

Key details:

Subcutaneous injection given every four weeks.
Tests whether monthly dosing sustains weight loss.
Assesses long-term patient adherence with fewer injections.
Primary endpoints:
- Change in body weight from baseline at Week 24.
- Percentage change in body weight at Week 24.
Led by Prof. Linong Ji of Peking University People’s Hospital.

The study is registered as CTR20254659.

What We Know From Earlier Trials?

Gan & Lee has already run two major Phase 3 studies: GRADUAL-1 and GRADUAL-2.

GRADUAL-1

A 52-week study in around 630 adults with obesity or overweight. It evaluated the weight-loss efficacy and safety of bofanglutide.

GRADUAL-2

A 52-week head-to-head study with semaglutide 2.4 mg (Wegovy®). It is the first global GLP-1 RA trial comparing a new candidate directly with Wegovy in Chinese adults. Participants included adults with or without type 2 diabetes.

What These Studies Indicate?

Strong weight-loss effects.
Glucose-lowering benefits.
Improvements in metabolic parameters and cardiovascular risk markers.
A safety profile consistent with current GLP-1 drugs.

Why GRADUAL-3 Matters?

The biggest challenge with GLP-1 therapies is long-term adherence. Weekly injections work—until people stop taking them.

A monthly regimen could:

Reduce treatment fatigue.
Improve adherence.
Help sustain weight loss.
Limit weight regain seen after stopping GLP-1 therapy.
Offer a more convenient real-world solution.

Inside the GRADUAL Clinical Program

The GRADUAL program includes three major Phase 3 trials with a planned enrollment of more than 1,000 participants.

The three trials:

GRADUAL-1
- 52 weeks
- ~630 adults
- Tests weight-loss efficacy and safety.
GRADUAL-2
- 52 weeks
- ~471 adults
- Compared with Wegovy
- Includes participants with and without type 2 diabetes.
GRADUAL-3
- 24 weeks
- Tests once-monthly dosing for weight-loss maintenance.

About Bofanglutide

Bofanglutide (GZR18) is Gan & Lee’s novel GLP-1 receptor agonist.

Current development focus:

Obesity and overweight
Type 2 diabetes

Clinical profile so far:

Strong weight-loss effects
Effective glucose lowering
Broad metabolic benefits
Safety comparable to marketed GLP-1 RAs

Bofanglutide is now advancing through global Phase 3 development.