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
Verified date | March 2019 |
Source | NGM Biopharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants
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 |
Country | Name | City | State |
---|---|---|---|
United States | Prosciento | Chula Vista | California |
Lead Sponsor | Collaborator |
---|---|
NGM Biopharmaceuticals, Inc |
United States,
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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