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GL0034 for Overweight or Obese Adults with Type 2 Diabetes

This study is testing an investigational drug called GL0034 for adults who have type 2 diabetes and are also overweight or obese. The goal is to see how well GL0034 works and if it's safe. You would receive GL0034 at one of five different dose levels, or a placebo (an inactive substance), as a weekly injection under the skin. Researchers will measure your HbA1c (a measure of average blood sugar over 2-3 months) levels to see if GL0034 helps. To join, you need to be at least 18 years old, have type 2 diabetes for at least 180 days, and have an HbA1c level between 7.0% and 10.5%. The study plans to enroll 285 participants, but its current status is unclear.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study. It will involve 285 participants who will be assigned to receive either GL0034 at one of five doses or a placebo.
What's involved
You would receive weekly subcutaneous injections of GL0034 or placebo. There will be an initial dose-up period lasting approximately 20 weeks, and your HbA1c levels will be measured at Week 36.
Compensation
Not stated in the trial record.
Follow-up
Your HbA1c levels will be measured at Week 36 to assess the treatment's effect.

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NCT07282743

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sun Pharmaceutical Industries Limited
~285 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:GL0034 Dose Level 1GL0034 Dose Level 2GL0034 Dose Level 3GL0034 Dose Level 4GL0034 Dose Level 5GL0034 Dose Level 6

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants
Measured over Week 36

Conditions

Type II Diabetes Mellitus

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

21 sites across 10 states
Florida5
Maharashtra5
Kansas2
Kerala2
National Capital Territory of Delhi2
Arkansas1
Oklahoma1
Andhra Pradesh1

Who to contact

Head, Regulatory Affairs
[email protected]
9122 66455645
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Participant has history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement.
Participant has history of other malignancy that have been adequately treated with no evidence of recurrence/relapse within the last 5 years, per Investigator's judgement. 17. Presence of diabetic retinopathy \[both nonproliferative diabetic retinopathy and proliferative diabetic retinopathy\]) or maculopathy in either eye that was verified by a fundoscopic examination within 90 days prior to screening or during the study. 18. Known moderate to severe coronary, carotid, or peripheral vascular disease that has planned or will likely need revascularization during the study. 19. Participants with any other condition, which in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment/interpretation of study outcomes). 20. Known hypersensitivity to the study IP or its excipients. 21. History of alcohol or drug abuse in the previous two years (Alcohol abuse in this study is defined as \>14 standard drinks per week in men or \>7 standard drinks per week in women ± a history of alcohol withdrawal symptoms ± institutionalized/hospitalized due to alcohol use ± binge drinking with \>5 standard drinks on a single occasion in men or \>4 standard drinks on a single occasion in women). 22. Participants are taking, or will start, medications with narrow therapeutic index such as digoxin, warfarin, etc, or those that will prolong QTc interval.

What this trial measures

  • Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participantsWeek 36