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NCT05762471
Randomized, Double-blind, Placebo-controlled Phase 1b Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects
Conditions: Overweight or Obesity
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1
Enrollment: 24
Sponsor: Gasherbrum Bio, Inc
Location: United States
Summary
This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV).This study includes 3 planned cohorts.
Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 28
Eligibility Criteria
Inclusion Criteria:Provided evidence of a signed consentAge ≥ 18 and ≤ 75 yearsHealthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2No nicotine useHave a suitable venous access for blood samplingExclusion Criteria: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 monthsA 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 intervalLiver function test results elevated > 2.0-fold above the ULN for gamma gutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase.
Bilirubin above the ULNEstimated glomerular filtration rate < 60mL/min/1.73 m2 body surface areaKnown hypersensitivity to any of the study drug ingredientsAny other condition or prior therapy that would make the participant unsuitable for this study
Source: ClinicalTrials.gov (NCT05762471). StuddyBuddy aggregates publicly available trial information.