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Efficacy and Safety 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
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 written 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 between 7.0% and 10.5% at screening
- Stable BMI of 27 kg/m2 or higher for at least 90 days before screening
- Able and willing to fast and perform 7-point self-monitoring blood glucose for 3 days before visits
- On stable daily metformin dose 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 barrier method during and 1 month after study
- Male participants with partners of childbearing potential must use barrier contraception during and 30 days after study
- Women of childbearing potential must have negative pregnancy tests before treatment
- Willing and able to follow study protocol and use electronic patient-reported outcome device
You will not qualify if you...
- History of type I diabetes mellitus
- Weight change over 5% within 90 days before screening
- History of pancreatitis or more than 3 hypoglycemic episodes in 90 days before screening
- Chronic kidney disease with eGFR below 60
- Poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Poorly controlled thyroid disorders
- Diabetes or obesity caused by endocrine disorders or medications
- Previous or planned obesity surgery or weight loss device during trial
- History of major depressive disorder in past 2 years or severe psychiatric illness
- Any lifetime history of suicide attempt
- Certain medical conditions affecting study safety or results as judged by investigator
- Recent heart attack, unstable angina, or stroke within past 6 months
- Personal or family history of certain thyroid cancers or heart rhythm problems
- Planned surgery during trial except minor procedures
- Active cancer except certain treated skin or other cancers without recurrence for 5 years
- Diabetic eye diseases or maculopathy confirmed by exam
- Moderate to severe vascular disease likely needing intervention
- Known allergy to study drug or ingredients
- History of alcohol or drug abuse in past 2 years
- Using medications with narrow therapeutic index or prolong QT interval
- Use of other diabetes treatments besides metformin within 90 days before screening
- Previous use of GLP-1 receptor agonists
- Use of weight loss supplements or medications within 90 days
- Participation in weight-loss programs within 90 days
- Elevated calcitonin levels
- Abnormal lab tests or uncontrolled diseases posing risk
- Positive urine drug screen for non-prescribed substances
- Significant ECG abnormalities or high risk of arrhythmias
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
Family First Medical Research Center
Hialeah Gardens, Florida, United States, 33175
Actively Recruiting
3
Alliance for Multispecialty Research (AMR Clinical) - Wichita East
Lakeland, Florida, United States, 33803
Actively Recruiting
4
CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
Lakeland, Florida, United States, 33803
Actively Recruiting
5
GTL Medical & Research Group
Miami, Florida, United States, 33173
Actively Recruiting
6
Florida Institute for Clinical Research LLC
Orlando, Florida, United States, 32835
Actively Recruiting
7
AMR Clinical, El Dorado
El Dorado, Kansas, United States, 67042
Actively Recruiting
8
AMR Clinical - Newton
Newton, Kansas, United States, 67114
Actively Recruiting
9
Lynn Health Science Institute - Oklahoma City
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
10
Endolife Specialty Hospitals Pvt. Ltd.
Guntur, Andhra Pradesh, India, 522001
Actively Recruiting
11
Life Care Hospital and Research Centre
Bangalore, Karnataka, India, 560092
Actively Recruiting
12
Government Medical College
Kozhikode, Kerala, India, 673008
Actively Recruiting
13
Jothydevs Diabetes Research Centre
Trivandrum, Kerala, India, 695032
Actively Recruiting
14
Nirmal Hospital Private Limited
Kolhāpur, Maharashtra, India, 416008
Actively Recruiting
15
Topiwala National Medical College & BYL Nair Hospital
Mumbai, Maharashtra, India, 400008
Actively Recruiting
16
Seth G. S. medical college and KEM hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
17
BSES Municipal General Hospital
Mumbai, Maharashtra, India, 400058
Actively Recruiting
18
LMMF's Deenanath Mangeshkar Hospital and Research Center
Pune, Maharashtra, India, 411004
Actively Recruiting
19
Lady Hardinge Medical College and S.S.K. Hospital
New Delhi, National Capital Territory of Delhi, India, 110001
Actively Recruiting
20
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
21
Madras Diabetes Research Foundation (MDRF)
Chennai, Tamil Nadu, India, 600086
Actively Recruiting
Research Team
H
Head, Regulatory Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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