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

NCT07282743 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2026-03-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-04-30
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282743 on ClinicalTrials.gov