Phase 1 Study of NGM313 in Healthy Adult Participants
Phase 1
Completed
- Conditions
- Obesity
- Registration Number
- NCT02708576
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- Brief Summary
The purpose of this study is to determine the safety and tolerability of NGM313, both single dose and multiple doses, in normal healthy overweight and obese adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
Inclusion Criteria
- BMI range 27-40 kg/m2, inclusive for the SAD module, and 27-40 kg/m2, inclusive for the MAD module;
- Normal clinical laboratory evaluations
- Normal ECG findings
Exclusion Criteria
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- Uncontrolled hypertension defined as sitting blood pressure systolic > 150 mm/Hg and/or diastolic > 90 mm/Hg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Absolute change in weight in kilograms 28 and 84 days
- Secondary Outcome Measures
Name Time Method Absolute change in fasting glucose in mmol/L 28 and 84 days
Trial Locations
- Locations (1)
NGM Clinical Study Site
🇦🇺Melbourne, Victoria, Australia
NGM Clinical Study Site🇦🇺Melbourne, Victoria, Australia