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NCT07282743 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
A Phase 2 study of Type II Diabetes Mellitus, sponsored by Sun Pharmaceutical Industries Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 285
- Enrollment target
- 20
- Study locations
NCT07282743: Recruiting Phase 2 study of Type II Diabetes Mellitus, sponsored by Sun Pharmaceutical Industries Limited.
NCT07282743 is a Phase 2 study of Type II Diabetes Mellitus that is actively recruiting participants, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 285 participants, above the 133-participant average among 7 other Type II Diabetes Mellitus trials with a reported enrollment target (114% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07282743, a Phase 2 study of Type II Diabetes Mellitus, is actively recruiting participants, sponsored by Sun Pharmaceutical Industries Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 285 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG GL0034 Dose Level 1
- DRUG GL0034 Dose Level 2
- DRUG GL0034 Dose Level 3
- DRUG GL0034 Dose Level 4
- DRUG GL0034 Dose Level 5
Study Locations (20)
Florida
- Family First Medical Research Center - Hialeah Gardens
- Alliance for Multispecialty Research (AMR Clinical) - Wichita East - Lakeland
- CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis) - Lakeland
- GTL Medical & Research Group - Miami
- Florida Institute for Clinical Research LLC - Orlando
Maharashtra
- Nirmal Hospital Private Limited - Kolhāpur
- Topiwala National Medical College & BYL Nair Hospital - Mumbai
- Seth G. S. medical college and KEM hospital - Mumbai
- BSES Municipal General Hospital - Mumbai
- LMMF's Deenanath Mangeshkar Hospital and Research Center - Pune
Kansas
- AMR Clinical, El Dorado - El Dorado
- AMR Clinical - Newton - Newton
Kerala
- Government Medical College - Kozhikode
- Jothydevs Diabetes Research Centre - Trivandrum
National Capital Territory of Delhi
- Lady Hardinge Medical College and S.S.K. Hospital - New Delhi
- All India Institute of Medical Sciences - New Delhi
Arkansas
- Lynn Institute of the Ozarks - Little Rock
Oklahoma
- Lynn Health Science Institute - Oklahoma City - Oklahoma City
Andhra Pradesh
- Endolife Specialty Hospitals Pvt. Ltd. - Guntur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
What NCT07282743 shows while recruiting
NCT07282743 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 7 other Type II Diabetes Mellitus trials with a reported enrollment target (114% higher).
The record links to 1 condition, with Type II Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which GL0034 Dose Level 1 is the first listed.
NCT07282743 names 20 study sites across 9 states, led by Florida, Maharashtra, Kansas.
Frequently Asked Questions
What is clinical trial NCT07282743 about?
NCT07282743 is a clinical study titled "Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus". 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, on...
What is the current status of trial NCT07282743?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 285 participants. The study started on 2026-01-20. Estimated completion is 2027-08.
What conditions does trial NCT07282743 study?
This clinical trial studies the following conditions: Type II Diabetes Mellitus.
What interventions are being tested in trial NCT07282743?
The interventions under investigation include: GL0034 Dose Level 1 (DRUG), GL0034 Dose Level 2 (DRUG), GL0034 Dose Level 3 (DRUG), GL0034 Dose Level 4 (DRUG), GL0034 Dose Level 5 (DRUG).
Who is sponsoring clinical trial NCT07282743?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07282743 being conducted?
This trial has 20 study locations across Arkansas, Florida, Kansas, Oklahoma, Andhra Pradesh. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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