Phase 1 Study of NGM313 in Healthy Adult Participants

Phase 1

Completed

• Conditions: Obesity
• Interventions: Other: Placebo; Biological: NGM313

• 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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administration of placebo comparator
NGM313	NGM313	Administration of active NGM313

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