Obesity
Conditions
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.
Interventions
BIOLOGICALNGM313
OTHERPlacebo
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in weight in kilograms | 28 and 84 days |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in fasting glucose in mmol/L | 28 and 84 days |
Other
| Measure | Time frame |
|---|---|
| Pharmacokinetics as measured by time to maximum concentration (tmax). | 28 and 84 days |
| Pharmacokinetics as measured by area under the curve (auc). | 28 and 84 days |
| Safety and tolerability as measured by adverse events, vitals signs, electrocardiograms, and clinical laboratories | 28 and 84 days |
| Pharmacokinetics as measured by maximum observed concentration (cmax). | 28 and 84 days |
Countries
Australia
Outcome results
None listed