Sun Pharmaceutical Industries Limited
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.
Inclusion Criteria: 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 cons…
Dose 1, once a week
Dose 2, once a week
Dose 3, once a week
Dose 4, once a week
Dose 5, once a week
Dose 6, once a week
Placebo, once a week