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

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

Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants (clinicaltrials.gov) - P2 | N=285 | Not yet recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • 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 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Genetic Disorders • Obesity

Gan & Lee Pharmaceuticals Announces U.S. FDA Clearance of the IND application for the innovative Bi-weekly GLP-1RA GZR18 Injection, Bofanglutide, with chronic weight management Indication (A Phase 2 head-to-head with Tirzepatide clinical trial) (Canada Newswire) - "Gan & Lee Pharmaceuticals...is pleased to announce that the Food and Drug Administration ('FDA') has cleared the Investigational New Drug (IND) application for GZR18 Injection to conduct a phase 2 clinical trial, a head-to-head with Tirzepatide from Eli Lilly and Company...in the US (NCT06737042). GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA) being developed by Gan & Lee Pharmaceuticals."

IND • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 2b Study of Bi-weekly GLP-1 RA GZR18 in Chinese Adults with Overweight/Obesity (OBESITY WEEK 2024) - "GZR18 demonstrated a robust body weight reduction in overweight/obese adults with either QW or Q2W dosing frequency. Furthermore, no significant difference in efficacy between the 48 mg Q2W and 24 mg QW dosages was observed. These results warrant the further development of bi-weekly GZR18 in phase 3 confirmatory trials for the management of overweight and obesity."

Clinical • P2b data • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus