GZR4 / Gan & Lee Pharma - LARVOL DELTA

Pharmacokinetic and pharmacodynamic properties of novel once-weekly insulin GZR4 versus insulin degludec in people with type 2 diabetes (EASD 2026) - P1 | "Based on this interim analysis, in individuals with T2D, once-weekly GZR4 showed a persistent glucose-lowering effect in an evenly daily distribution pattern over a full week dosing interval. The PK profile of GZR4 — characterized by a long terminal half-life (149 h) and sustained exposure through 168 h post-dose — supports once-weekly dosing. GZR4 was found to have a higher molar potency than IDeg."

Late-breaking abstract • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetic and pharmacodynamic profiles of GZR102, a novel once-weekly fixed-ratio combination of insulin GZR4 and GLP-1 receptor agonist bofanglutide (EASD 2026) - "This contrasts with the PK profile of IcoSema, which exhibited significant drug-drug interactions on C max and T max . The combination of GZR4 and GZR18 in GZR102 did not affect the PK of the individual components compared with mono- component treatments. GZR102 demonstrated greater improvements in glycemic control, body weight reduction, and lipid metabolism compared with mono-component treatments. These findings support the further clinical development of GZR102 as a once-weekly FRC targeting both insulin and GLP-1 receptor pathways simultaneously."

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

Superior glycaemic control with once-weekly insulin GZR4 versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: SUPER-1 (EASD 2026) - P3 | "In the SUPER-1 trial, once-weekly GZR4 demonstrated superior HbA 1c reduction compared to once-daily glargine U100 in insulin-naïve adults with type 2 diabetes under a similar weekly insulin dose. Moreover, GZR4 enabled more participants to achieve glycaemic treatment targets with a comparable risk of level 2 or 3 hypoglycaemia to that of glargine U100, supporting its potential as a safe and effective once-weekly basal insulin option."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Superior glycaemic control with once-weekly insulin GZR4 versus once-daily insulin degludec in adults with basal insulin-treated type 2 diabetes: SUPER-2 (EASD 2026) - P3 | "In the SUPER-2 trial, once-weekly GZR4 demonstrated a superior HbA 1c reduction compared with once-daily IDeg in adults with basal insulin-treated type 2 diabetes at a similar weekly insulin dose, and enabled more participants to achieve glycaemic targets, with a comparable risk of level 2 or 3 hypoglycaemia to that of IDeg. Moreover, glycaemic parameters were quickly and effectively controlled without a one-time additional GZR4 loading dose while switching from a daily basal insulin dose. GZR4 may facilitate adherence to insulin therapy by reducing basal insulin injections and simplifying the dosing regimen."

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

Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial

Safety, Tolerability, and Pharmacokinetic Characteristics of GZR102 Injection Compared with GZR4 or Bofanglutide (ADA 2026) - "The combination of GZR4 and GZR18 in GZR102 had no significant effect on GZR4 PK or GZR18 total exposure, but did slightly increase the Cmax of GZR18. GZR102 showed favorable safety and tolerability."

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) - "The combination of GZR4 and GZR18 in GZR102 did not affect the PK of the individual components. GZR102 demonstrated complementary glycemic control and metabolic benefits including weight reduction and lipid metabolism. These findings support the further clinical development of GZR102 as a once-weekly FRC."

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

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