Phase 1 Study of NGM313 in Healthy Adult Participants

A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM313 in Healthy Overweight and Obese Adult Participants

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Placebo; Biological: NGM313

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • NGM Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NGM313; Administration of active NGM313	Biological: NGM313
Placebo Comparator: Placebo; Administration of placebo comparator	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change in weight in kilograms	28 and 84 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute change in fasting glucose in mmol/L	28 and 84 days

Other Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc
• Investigators: Study Director: Que Liu, MD, NGM Biopharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15-0201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO