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NCT03298464 Clinical Trial

Study of NGM313 in Obese Participants

Obese Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03298464
Other study ID # 17-0202
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 11, 2017
Est. completion date July 17, 2018

Study information
Verified date March 2019
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 17, 2018
Est. primary completion date June 19, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• NGM313
Subcutaneous injection
Drug:
• Pioglitazone
White to off-white round tablet

Locations
Country Name City State
United States Prosciento Chula Vista California

Sponsors (1)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration 28 Days
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