RecruitingPhase 2NCT07282743

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


Sponsor

Sun Pharmaceutical Industries Limited

Enrollment

285 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether GL0034, a new injectable drug, is safe and effective at lowering blood sugar and supporting weight loss in adults with type 2 diabetes who are overweight or obese. **You may be eligible if...** - You are 18 or older - You were diagnosed with type 2 diabetes at least 180 days before the study - Your HbA1c (a measure of blood sugar control over time) is between 7.0% and 10.5% - Your BMI is 27 or higher and has been stable for the past 90 days - You have been on a stable dose of metformin for at least 90 days - You are able to do fasting blood draws and check your blood sugar at home **You may NOT be eligible if...** - You have type 1 diabetes - You have had weight-loss surgery - Your blood sugar or other health conditions are not stable - You have serious organ problems that would make the study drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGL0034 Dose Level 1

Dose 1, once a week

DRUGGL0034 Dose Level 2

Dose 2, once a week

DRUGGL0034 Dose Level 3

Dose 3, once a week

DRUGGL0034 Dose Level 4

Dose 4, once a week

DRUGGL0034 Dose Level 5

Dose 5, once a week

DRUGGL0034 Dose Level 6

Dose 6, once a week

OTHERPlacebo

Placebo, once a week


Locations(21)

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

Family First Medical Research Center

Hialeah Gardens, Florida, United States

Alliance for Multispecialty Research (AMR Clinical) - Wichita East

Lakeland, Florida, United States

CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

Lakeland, Florida, United States

GTL Medical & Research Group

Miami, Florida, United States

Florida Institute for Clinical Research LLC

Orlando, Florida, United States

AMR Clinical, El Dorado

El Dorado, Kansas, United States

AMR Clinical - Newton

Newton, Kansas, United States

Lynn Health Science Institute - Oklahoma City

Oklahoma City, Oklahoma, United States

Endolife Specialty Hospitals Pvt. Ltd.

Guntur, Andhra Pradesh, India

Life Care Hospital and Research Centre

Bangalore, Karnataka, India

Government Medical College

Kozhikode, Kerala, India

Jothydevs Diabetes Research Centre

Trivandrum, Kerala, India

Nirmal Hospital Private Limited

Kolhāpur, Maharashtra, India

Topiwala National Medical College & BYL Nair Hospital

Mumbai, Maharashtra, India

Seth G. S. medical college and KEM hospital

Mumbai, Maharashtra, India

BSES Municipal General Hospital

Mumbai, Maharashtra, India

LMMF's Deenanath Mangeshkar Hospital and Research Center

Pune, Maharashtra, India

Lady Hardinge Medical College and S.S.K. Hospital

New Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Madras Diabetes Research Foundation (MDRF)

Chennai, Tamil Nadu, India

View Full Details on ClinicalTrials.gov

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NCT07282743


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