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RECRUITING
NCT07282743
PHASE2

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

Sponsor: Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2026-01-20

Completion Date

2027-08

Last Updated

2026-03-18

Healthy Volunteers

No

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

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