Condition: Overweight or Obesity · Type2 Diabetes Mellitus · Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
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
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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Inclusion Criteria cohorts 1-4: 1. Provided evidence of a signed consent 2. Age ≥ 18 and ≤ 75 years 3. Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 4. No nicotine use 5. Have a suitable venous access for blood sampling Inclusion Criteria cohort 5: 1. Men and women with T2DM of ≥6 months duration 2. Age ≥ 18 and ≤ 75 years 3. BMI ≥ 27 and ≤ 40 kg/m2 4. Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%. Exclusion Criteria: 1. 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 2. 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. 3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval 4. 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 5. Estimated glomerular filtration rate \< 60mL/min/1.73 m2 body surface area 6. Known hypersensitivity to any of the study drug ingredients 7. Any other condition or prior therapy that would make the participant unsuitable for this study
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
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