GZR4 / Gan & Lee Pharma - LARVOL DELTA

Safety, Tolerability, and Pharmacokinetic Characteristics of GZR102 Injection Compared with GZR4 or Bofanglutide (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • PK/PD data • Metabolic Disorders

Pharmacokinetic and Pharmacodynamic Profiles of GZR102 Injection, a Novel Once-Weekly Fixed-Ratio Combination of Insulin GZR4 and GLP-1 Analog Bofanglutide (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

PK/PD data • Metabolic Disorders

Once-weekly insulin GZR4 versus once-daily insulin degludec in Chinese people with type 2 diabetes: A multicenter, open-label, randomized, phase 2 trial. (PubMed, Metabolism) - "In this phase 2 trial, once-weekly GZR4 demonstrated effective glycemic control over 16 weeks in both insulin-naïve patients and those previously treated with basal insulin. The incidence of hypoglycemia was slightly higher with GZR4, particularly in the basal insulin-treated group, though no severe hypoglycemic events were reported. These findings warrant further investigation in larger phase 3 trials, which will utilize an adjusted, more precise molar-dose potency of GZR4 to fully characterize its benefit-risk profile."

Journal • P2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Pharmacokinetic properties of insulin GZR4 after subcutaneous administration in the thigh, abdomen, or upper arm in healthy participants. (PubMed, Diabetes Obes Metab) - "In healthy Chinese participants, subcutaneous injection of GZR4 in the thigh, abdomen, or upper arm displayed comparable drug exposure, with no clinically meaningful differences observed among the injection regions."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders

A phase 1b, randomized, open-label study of once-weekly insulin GZR4 in patients with type 2 diabetes mellitus. (PubMed, Diabetes Res Clin Pract) - "GZR4 was safe and well tolerated in patients with diabetes in present trial with PK and PD profiles enabling once-weekly dosing."

Journal • P1 data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

GZR4-T2D-301: A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P3 | N=580 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2026 ➔ Aug 2026

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

Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Hepatology • Metabolic Disorders

A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial Insulin (clinicaltrials.gov) - P3 | N=580 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting

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

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

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

GZR4-T2D-302: A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=620 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Recruiting ➔ Active, not recruiting

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

Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Diabetes • Hepatology • Metabolic Disorders

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

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

Comparable glycaemic control of once-weekly insulin GZR4 relative to once-daily insulin degludec in insulin-naive Chinese participants with type 2 diabetes (EASD 2025) - P2 | "GZR4 demonstrated comparable efficacy and safety profiles to QD IDeg in participants with T2D, achieving similar outcomes with a lower insulin dose. GZR4 is promising to be a safe and effective QW insulin in diabetes management."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Superior glycaemic control achieved with once-weekly insulin GZR4 compared to once-daily insulin degludec in insulin-treated Chinese participants with type 2 diabetes (EASD 2025) - P2 | "GZR4 demonstrated superior HbA1c reduction after 16 weeks of treatment in insulin-treated participants with T2D and is promising to be a safe and effective QW basal insulin in diabetes management."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison Study of Insulin GZR4 With Insulin Degludec (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

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

Superior Glycemic Control Achieved with Once-Weekly Insulin GZR4 Compared with Once-Daily Insulin Degludec in Insulin-Treated Chinese Subjects with T2D (ADA 2025) - "GZR4 demonstrated superior HbA1c reduction after 16 weeks of treatment in insulin-treated subjects with T2D and is promising to be a safe and effective QW basal insulin in diabetes management."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparable Glycemic Control of Once-Weekly Insulin GZR4 Relative to Once-Daily Insulin Degludec in Insulin-Naïve Chinese Subjects with T2D (ADA 2025) - "GZR4 demonstrated comparable efficacy and safety profiles to QD IDeg in subjects with T2D, achieving similar outcomes with a lower insulin dose. GZR4 is promising to be a safe and effective QW insulin in diabetes management."

Clinical • Hypoglycemia • Metabolic Disorders • 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

Safety, tolerability, pharmacokinetics and pharmacodynamics of GZR4, a novel once-weekly basal insulin, in healthy participants: A randomized trial. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • PK/PD data

GZR4-T2D-302: A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=620 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

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

Safety, tolerability, pharmacokinetics and pharmacodynamics of GZR4, a novel once-weekly basal insulin, in healthy participants: A randomized trial. (PubMed, Diabetes Obes Metab) - "Once-weekly GZR4 demonstrated good safety and tolerability in healthy participants. It exhibited a dose-dependent and sustained glucose-lowering effect over a full week and demonstrated stronger daily glucose-lowering efficacy than once-daily IDeg under similar molar concentrations. These results support further investigation of once-weekly GZR4 for glycaemic control in patients with diabetes."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders

A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects with Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) - P3 | N=580 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

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

A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated with Basal + Prandial Insulin (clinicaltrials.gov) - P3 | N=580 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

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

A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects with Type 2 Diabetes Mellitus Treated with Basal Insulin (clinicaltrials.gov) - P3 | N=620 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

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

Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Recruiting ➔ Completed | N=28 ➔ 16

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Renal Disease