GZR4 / Gan & Lee Pharma - LARVOL DELTA

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

Pharmacokinetic and pharmacodynamic properties of a novel once-weekly insulin analogue GZR4 in people with type 2 diabetes (EASD 2024) - "Thirty-six eligible adults (aged 18-65 years, BMI 18.5-35 kg/m 2 , with HbA1c 6.5%-10.0% and Fasting Blood Glucose [FBG] < 13.9 mmol/L) were randomised 3:1 to receive a once-weekly fixed dosage of GZR4 (6, 8, 12 nmol/kg) or once-daily insulin degludec (IDeg) (equal to the pre-enrolment daily basal insulin dosage) subcutaneously for six weeks. Once-weekly GZR4 was overall safe and well tolerated in the current trial with PK/PD profile enabling once-weekly dosing. The findings support the further development of GZR4 as a once-weekly treatment option for glycaemic control in diabetic population."

PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety, tolerability, and pharmacodynamics properties of a novel once-weekly insulin GZR4 in healthy subjects (EASD 2024) - "In cohorts 1-4, participants were randomized in a 4:1 ratio to once-weekly subcutaneous injection of GZR4 (doses: 1 ,3 ,6 ,12 nmol/kg) or placebo, and cohort 5 administered with 0.4 U/kg of insulin degludec (IDeg) as a comparator. GZR4 exhibits good tolerability in healthy subjects and a superior glucose-lowering effect compared to IDeg. The safety, PK, and PD profiles of GZR4 support further evaluation of once-weekly dosing regimens for glycemic management in patients with diabetes."

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

A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Recruiting ➔ Completed

Combination therapy • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA

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

A Study of GZR4 Injection at Different Injection Sites (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

New P1 trial