Study of NGM313 in Obese Participants

Phase 1

Completed

• Conditions: Obese
• Interventions: Biological: NGM313; Drug: Pioglitazone

• Registration Number: NCT03298464
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-11
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-10-02
• Primary Completion: 2018-06-19
• Study Completion: 2018-07-17
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGM313	NGM313	-
Pioglitazone	Pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration	28 Days

Trial Locations

Locations (1)

Prosciento; 🇺🇸 Chula Vista, California, United States