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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Overweight or Obesity, Type2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT05762471

Run by

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

People needed

142

Starts

2023-01-09

Expected to finish

2024-04-11

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months
• A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute.
• Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
• Liver function test results elevated > 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
• Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area
• Known hypersensitivity to any of the study drug ingredients
• Any other condition or prior therapy that would make the participant unsuitable for this study

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States
• ProSciento, Inc — Chula Vista, California, United States
• QPS Miami Research Associates — Miami, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States

Full record on ClinicalTrials.gov

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