Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: Sun Pharmaceutical Industries Limited
You may qualify if…
- ✓ 1. Participant is willing and able to sign a written ICF or e-ICF.
- ✓ 2. Men or women ≥18 years of age at the time of signing ICF or e-ICF.
- ✓ 3. Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.
- ✓ 4. Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.
- ✓ 5. Participant has a stable BMI ≥27 kg/m2 for at least 90 days prior to screening.
- ✓ 6. Participant is able and willing to undergo fasting blood draw (i.e. at least 8 hours after last eating or drinking) as well as 7-point SMBG check for 3 consecutive days prior to designated scheduled visits by using a home glucometer that is provided by the study site.
- ✓ 7. Participant on stable daily doses of metformin for at least 90 days prior to screening.
- ✓ 8. Participant who are on metformin and not the following agents for at least 3 months prior to screening: DPP-4 inhibitors, alpha-glucosidase enzyme inhibitors, sulfonylureas, sodium-glucose transport 2 inhibitors, amylin analogues, thiazolidinediones, any insulin product, herbals, or ayurvedic agents. Participants are encouraged to follow the standard of care in their study regions, including appropriate diet and lifestyle modifications, rather than make abrupt change in the diabetic management prior to screening without consulting their physicians.
You may not qualify if…
- ✕ 1. Participants who have a history of type I diabetes mellitus.
- ✕ 2. A self-reported change in \>5% of body weight within 90 days before screening irrespective of medical records.
- ✕ 3. History of pancreatitis (acute or chronic) or \>3 hypoglycemic episodes (blood glucose level \<70 mg/dL or 3.9 mmol/L) within 90 days prior to screening.
- ✕ 4. Diagnosis of chronic kidney disease with estimated glomerular filtration rate \<60.
- ✕ 5. Poorly controlled hypertension with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg.
- ✕ 6. Poorly controlled hypothyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L.
- ✕ 7. Diabetes mellitus and/or obesity that is induced by endocrine disorders (e.g. Cushing Syndrome) or medication use (e.g. corticosteroids) as judged by the Investigator.
- ✕ 8. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed \>1 year before screening is allowed). Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, previous interventions that, due to reversal or removal, does not have any influence on the participant's weight, in the opinion of the Investigator, are allowed.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07282743 · last updated 2026-03-18