Study of NGM313 in Obese Participants

The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants

Completed

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prosciento

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Body mass index (BMI) of 30-43 kg/m2
Waist circumference > 40 inches in males or > 30 inches in females
Normal ECG readings

Exclusion criteria

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
History of any known Congestive heart failure (CHF)
History of macrovascular disease

Treatment and study plan

NGM313

Biological

Subcutaneous injection

pioglitazone

Drug

White to off-white round tablet

Primary outcomes

Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration

Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

A Phase 1B, Single Center, Randomized, Open Label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single NGM313 Dose or Daily Oral Pioglitazone in Obese Participants With Insulin Resistance and Increased Liver Fat

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 2, 2017
Registry last updated: Mar 13, 2019

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.

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

Completed