About this trial
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.
Eligibility criteria
Qualifiers
Participant is willing and able to sign a written ICF or e-ICF.
Men or women ≥18 years of age at the time of signing ICF or e-ICF.
Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.
Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.
Disqualifiers
Participants who have a history of type I diabetes mellitus.
A self-reported change in >5% of body weight within 90 days before screening irrespective of medical records.
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.
Diagnosis of chronic kidney disease with estimated glomerular filtration rate <60.
Trial design
Treatments tested in this trial
- GL0034 Dose Level 1
- GL0034 Dose Level 2
- GL0034 Dose Level 3
- GL0034 Dose Level 4
- GL0034 Dose Level 5
- GL0034 Dose Level 6
- Placebo