bofanglutide (GZR18) / Gan & Lee Pharma, Lupin - LARVOL DELTA

GYG1 as a Dual Biomarker of Glucagon-Like Peptide-1 Receptor Agonist Weight-Loss Response: Findings from an Integrative Multi-Omics Substudy of a Phase II Trial. (PubMed, Endocrinol Metab (Seoul)) - "We investigated circulating multi-omics signatures for predicting and monitoring glucagon-like peptide-1 receptor agonist (GLP-1RA) (GZR18) response, addressing gaps in personalized obesity therapy...This study establishes GYG1 as a clinically actionable, dual-function biomarker for GLP-1RA therapy in obesity, linking baseline prediction and real-time monitoring of treatment response through integrated multi-omics profiling. Our findings highlight convergent metabolic pathways driving therapeutic efficacy and provide a precision-medicine framework for optimizing obesity pharmacotherapy through blood-based molecular signatures."

Biomarker • Journal • P2 data • Genetic Disorders • Obesity • IGFBP2

Bioequivalence Study of GZR18 Injection Before and After CMC Change (clinicaltrials.gov) - P1 | N=138 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Genetic Disorders • Obesity

Lupin announced that it has entered into an exclusive license, supply, and distribution agreement with China-based Gan & Lee Pharmaceuticals for Bofanglutide, a novel fortnightly GLP-1 receptor agonist. (Business Standard)

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

GZR18-BWM-303: Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Genetic Disorders • Obesity

Once-Monthly GLP-1 RA | Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management (PRNewswire) - "In this study, bofanglutide injection will be administered subcutaneously once every four weeks (once-monthly) to explore its potential to maintain the achieved weight loss and improved long-term adherence....This phase 3 study (Chinadrugtrials.org.cn: CTR20254659) is designed to evaluate the efficacy and safety of once-monthly bofanglutide injection on body weight after 24 weeks of continuous treatment."

Trial status • Obesity

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Optimum 2: A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=1100 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2026 ➔ Dec 2026

Enrollment closed • Monotherapy • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects (clinicaltrials.gov) - P3 | N=630 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Optimum 1: A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise (clinicaltrials.gov) - P3 | N=274 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Study of [14C] GZR18 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Gan & Lee Pharmaceuticals. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Efficacy and safety of bofanglutide (GZR18), a bi-weekly GLP-1 RA, compared to semaglutide in Chinese patients with type 2 diabetes (EASD 2025) - P2 | "In Chinese patients with T2D, GZR18 Q2W showed a comparable or superior HbA1c and weight reduction than SEMA 1mg QW. This study warrants phase 3 trials of bi-weekly dosing of GZR18 in treating T2D."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Genetic Disorders • Obesity

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Genetic Disorders • Liver Failure • Obesity

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Genetic Disorders • Obesity • Renal Disease

The Study of [14C] GZR18 (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Genetic Disorders • Obesity

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Genetic Disorders • Obesity

A Study to Compare the Efficacy and Safety of GZR102 Injection and GZR18 Injection in Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bofanglutide (GZR18), a Novel GLP-1RA, Improved Glycemic Control and Cardiometabolic Risk Factors in Chinese Patients with T2D (ADA 2025) - "GZR18 was well-tolerated in Chinese patients with T2D, demonstrating significant HbA1c reductions alongside comprehensive benefits for body weight, blood pressure and blood lipid profiles. These findings further support the exploration of GZR18's dosing frequency in the phase 2b trial and cardiometabolic outcomes in future GZR18 clinical trials."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Bofanglutide (GZR18), a Biweekly GLP-1RA, Compared with Semaglutide in Chinese Patients with T2D (ADA 2025) - "This randomized, open-label, phase 2b trial aimed to evaluate the efficacy and safety of a novel bi-weekly (Q2W) GLP-1 RA, bofanglutide (GZR18), compared to once-weekly (QW) semaglutide (SEMA, Ozempic®) in Chinese patients with T2D. A total of 272 eligible adult patients (HbA1c 7-11%) who were drug-naïve or on stable treatment with OADs were randomized 1:1:1:1:1 into one of four GZR18 groups (12, 18, 24 mg Q2W and 24 mg QW) or the SEMA group (1 mg QW) for 24 weeks. In Chinese patients with T2D, GZR18 Q2W showed a comparable or superior HbA1c and weight reduction than SEMA 1mg QW. This study warrants phase 3 trials of bi-weekly dosing of GZR18 in treating T2D."

Clinical • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

A Phase I Study to Evaluate the PK and PD Profiles of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Gan & Lee Pharmaceuticals Announced First Participant Dosed in the US Phase 2 Clinical Study of Bofanglutide (GZR18) Injection for Overweight or Obesity (PRNewswire) - "Gan & Lee Pharmaceuticals...announced that the first participant has been successfully dosed in a Phase 2 clinical trial of bofanglutide (research code: GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) independently developed by Gan & Lee, in the US participants with overweight or obesity....This Phase 2 clinical trial...was designed to evaluate the efficacy and safety of bofanglutide injection in US adults with overweight or obesity."

Trial status • Obesity

The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. (PubMed, Diabetes Obes Metab) - "GZR18 demonstrates good tolerability in healthy American and Chinese subjects. No ethnic differences were observed between healthy American and Chinese subjects. The safety, PK and PD profiles of GZR18 support its further clinical evaluation for glycaemic and body weight control."

Clinical • Journal • PK/PD data • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Obesity

Optimum 1: A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise (clinicaltrials.gov) - P3 | N=270 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Optimum 2: A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

Monotherapy • New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus