NCT07282743

Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of GL0034 Among Type II Diabetes Mellitus Subjects Who Are Obese or Overweight With Weight-related Comorbidities

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	GL0034 Dose Level 1	Dose 1, once a week
DRUG	GL0034 Dose Level 2	Dose 2, once a week
DRUG	GL0034 Dose Level 3	Dose 3, once a week
DRUG	GL0034 Dose Level 4	Dose 4, once a week
DRUG	GL0034 Dose Level 5	Dose 5, once a week
DRUG	GL0034 Dose Level 6	Dose 6, once a week
OTHER	Placebo	Placebo, once a week

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-04-01
• Completion: 2027-08-01
• First posted: 2025-12-15
• Last updated: 2026-03-18

Locations

21 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study