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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05762471). StuddyBuddy aggregates publicly available trial information.