Actively Recruiting
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
Led by Sun Pharmaceutical Industries Limited · Updated on 2026-03-18
285
Participants Needed
21
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and tolerability of GL0034 in adults with type II diabetes mellitus who are overweight or obese and have weight-related health issues. This phase II, randomized, double-blind, placebo-controlled study aims to assess how GL0034 affects blood sugar control, specifically measuring changes in HbA1c levels over time. The study includes participants who have had type II diabetes for at least six months and meet specific blood sugar and body mass index BMI criteria. Participants will be randomly assigned to one of five groups four groups receiving different dose levels of GL0034 and one group receiving a placebo. The treatment begins with a dose up-titration period lasting about 20 weeks, where doses are gradually increased. After reaching the final dose, participants continue weekly subcutaneous injections of their assigned dose through Week 48. The placebo group follows a similar schedule with sham injections. Throughout the study, participants will undergo regular blood tests, including fasting blood draws and blood sugar monitoring using a home glucometer. Researchers will measure changes in HbA1c levels at Weeks 36 and 48, as well as track body weight, BMI, and the proportion of participants achieving specific weight loss milestones. Participants will also record responses using an electronic patient-reported outcomes device to support data collection. Safety and tolerability will be monitored throughout the trial, which is expected to conclude in August 2027.
CONDITIONS
Brief Title
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign informed consent
- Men or women aged 18 years or older at consent
- Diagnosed with type II diabetes mellitus at least 180 days before screening
- HbA1c level between 7.0% and 10.5% at screening
- Stable body mass index (BMI) of 27 kg/m2 or higher for at least 90 days before screening
- Able and willing to perform fasting blood draws and 7-point self-monitoring of blood glucose for 3 days before visits
- On stable daily doses of metformin for at least 90 days before screening
- Not using other diabetes medications besides metformin for at least 3 months before screening
- Women of childbearing potential must use highly effective contraception plus a barrier method during study and for 1 month after last dose
- Male participants with female partners of childbearing potential must use barrier contraception during study and for 30 days after last dose
- Women of childbearing potential must have negative pregnancy tests before treatment
- Willing and able to comply with study procedures and use electronic patient-reported outcome device
You will not qualify if you...
- History of type I diabetes mellitus
- Weight change greater than 5% within 90 days before screening
- History of pancreatitis or more than 3 hypoglycemic episodes in 90 days before screening
- Chronic kidney disease with estimated glomerular filtration rate below 60
- Poorly controlled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Poorly controlled thyroid disease
- Diabetes or obesity caused by endocrine disorders or medications
- Previous or planned obesity surgery or weight loss devices during study
- History of major depression within 2 years or severe psychiatric illnesses
- Any lifetime history of suicide attempts
- Medical conditions that could affect study results or safety
- Recent heart attack, unstable angina, or stroke within 6 months
- Personal or family history of certain thyroid cancers or heart rhythm disorders
- Scheduled surgery during study period except minor procedures
- Active cancer or certain past cancers without recurrence in last 5 years
- Diabetic eye disease or maculopathy verified within 90 days before screening
- Known moderate to severe vascular disease likely needing intervention
- Other conditions posing risk or interfering with study assessments
- Known allergy to study drug or ingredients
- History of alcohol or drug abuse in last 2 years
- Use of certain medications affecting heart rhythm or diabetes
- Use of GLP-1 agonists or weight loss drugs within 90 days before screening
- Participation in weight reduction programs within 90 days before screening
- High calcitonin levels at screening
- Abnormal lab or ECG results posing risk
- Pregnant or breastfeeding females
Research Team
H
Head, Regulatory Affairs
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