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  1. Home
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  3. Gan Lee Begins Gradual 3 A New Phase 3 Trial For Its Once Monthly Glp 1 Bofanglutide
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  • 28 Nov 2025
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  • 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:

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

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