NCT05762471

Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

A Phase 1b/2a, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus on Metformin

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84

Conditions

• Overweight or Obesity
• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	GSBR-1290	Patients will receive GSBR-1290 or matching Placebo
DRUG	Placebo	Patients will receive GSBR-1290 or matching Placebo

Timeline

• Start date: 2023-01-09
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2023-03-09
• Last updated: 2024-04-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study