drugset / Trial / NCT07282743

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

NCT07282743 ↗

Phase 2 Recruiting 285 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-01-20
Primary completion
2027-04
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GL0034 Unknown — Subcutaneous