Skip to main content
OpenTrials
Completed

NCT Number: NCT02708576

Phase 1 Study of NGM313 in Healthy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NGM Clinical Study Site

Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM313

Biological

Placebo

Other

Primary outcomes

  1. Absolute change in weight in kilograms

    Time frame: 28 and 84 days

Secondary outcomes

  1. Absolute change in fasting glucose in mmol/L

    Time frame: 28 and 84 days

Other outcomes

  1. Safety and tolerability as measured by adverse events, vitals signs, electrocardiograms, and clinical laboratories

    Time frame: 28 and 84 days

  2. Pharmacokinetics as measured by maximum observed concentration (cmax).

    Time frame: 28 and 84 days

  3. Pharmacokinetics as measured by time to maximum concentration (tmax).

    Time frame: 28 and 84 days

  4. Pharmacokinetics as measured by area under the curve (auc).

    Time frame: 28 and 84 days

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2016
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.