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

Bofanglutide (GZR18), a Novel GLP-1RA, Improved Glycemic Control and Cardiometabolic Risk Factors in Chinese Patients with T2D (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • 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) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Metabolic Disorders • 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

A Phase I Clinical Study to Evaluate the Effect of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochloride Tablets in Overweight/Obese Subjects (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

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

A Study of GZR18 Tablet in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=92 | Active, not recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

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

A Phase I Study of GZR18 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA

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

A Phase I Study of GZR18 Injection in Obese/Overweight Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA

New P1 trial • Genetic Disorders • Obesity

A Study of GZR18 Injection in Obese/Overweight Patients (clinicaltrials.gov) - P2 | N=340 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Novel GLP-1 Analog, GZR18, Induced an 18.6% Weight Reduction in Subjects with Obesity in a Phase Ib/IIa Trial (ADA 2024) - "Its weight-loss effects surpassed those of Semaglutide (2.4 mg) and Tirzepatide (15 mg) in recent phase 3 trials involving similar Chinese populations (-9.8% and -17.5%, respectively). These findings warrant further investigation into GZR18's potential to offer superior weight management efficacy over multi-target incretin analogs"

Clinical • Late-breaking abstract • P1/2 data • Metabolic Disorders • Obesity

Gan & Lee Pharmaceuticals Announces Significant Progress on New Diabetes and Obesity Treatments at the American Diabetes Association's 84th Scientific Sessions (Yahoo Finance) - P1/2 | N=60 | NCT06256536 | Sponsor: Gan and Lee Pharmaceuticals, USA | "Gan & Lee Pharmaceuticals...announced the results of the Phase 1b/2a clinical study of...GZR18 Injection, in an obese/overweight population in China, along with the results of two other innovative insulins' preclinical studies in poster presentations at the American Diabetes Association's（ADA's）84th Scientific Sessions....The study results demonstrated a superior efficacy of GZR18 Injection than placebo for weight reduction in Chinese obese subjects. After 35 weeks of treatment, the mean weight change from baseline in the GZR18 QW group was -16.5 kg (95% CI: -19.9 kg, -13.1 kg); the placebo-adjusted mean percent weight change from baseline was -18.6% (95% CI: -25.5%, -11.6%). Although it was not a head-to-head study, when compared to the published data on weight reduction of similar products currently available on the market, GZR18's weight-reducing ability outperformed..."

P1/2 data • Metabolic Disorders • Obesity

A Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients (clinicaltrials.gov) - P2 | N=340 | Active, not recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

New P2 trial • Genetic Disorders • Obesity

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=272 | Active, not recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

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

A Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients (clinicaltrials.gov) - P1/2 | N=60 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA

New P1/2 trial • Genetic Disorders • Obesity

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P1/2 | N=72 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA

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

Gan & Lee Pharmaceuticals: GZR18 begins phase IIa clinical trials in China [Google translation] (jrj.com) - "The company responded: The company's clinical team has led and supported multiple R&D projects from multiple dimensions such as clinical research, operations, registration, and pharmacovigilance, and has successfully advanced multiple projects to the clinical stage at home and abroad. Take GZR18, an investigational drug in the fields of obesity/overweight weight management and type 2 diabetes, as an example. The project will begin Phase IIa clinical trials in China in 2023."

Trial status • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Ganli Pharmaceuticals (603087.SH): Clinical trial application for antidiabetic drug GZR18 tablets approved [Google translation] (jrj.com) - "Zhitong Finance APP News, Ganli Pharmaceutical...announced that the company’s wholly-owned subsidiary Ganli Pharmaceutical Shandong Co., Ltd. ('Ganli Shandong') recently received a notice from the National Medical Products Administration regarding the company’s drug under development GZR18 The 'Drug Clinical Trial Approval Notice' of the film, the acceptance numbers are CXSL2300633, CXSL2300634, and CXSL2300635, and the notice numbers are 2023LP02424, 2023LP02425, and 2023LP02426."

New trial • Diabetes • Metabolic Disorders

Gan & Lee Pharmaceutical GZR18 completes the administration of the first subjects in two phase IIb clinical trials [Google translation] (Daily Economic News - NBD) - "...Gan & Lee Pharmaceuticals announced that the company's self-developed long-acting GLP-1 receptor agonist (GLP-1 RA) new drug GZR18 has completed two Chinese trials for adult type 2 diabetes mellitus (T2DM) and obesity/overweight respectively. The first subject of Phase IIb clinical study was administered. Preclinical data show that GZR18 has the potential to lower blood sugar and reduce body weight, and some completed clinical studies have confirmed that GZR18 has excellent blood sugar and weight loss effects in humans, and has a good safety profile. Currently, the global development of GZR18 has entered phase II clinical research."

Clinical data • Preclinical • Trial completion • Trial status • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Recruiting ➔ Completed | N=56 ➔ 24

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus