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

Summary

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

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  GL0034 Dose Level 1

  Dose 1, once a week

• Drug
  GL0034 Dose Level 2

  Dose 2, once a week

• Drug
  GL0034 Dose Level 3

  Dose 3, once a week

• Drug
  GL0034 Dose Level 4

  Dose 4, once a week

• Drug
  GL0034 Dose Level 5

  Dose 5, once a week

• Drug
  GL0034 Dose Level 6

  Dose 6, once a week

• Other
  Placebo

  Placebo, once a week

Locations (21)