Back to resultsStudy of NGM313 in Obese Participants
Primary Purpose
Obese
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NGM313
Pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Obese
Eligibility Criteria
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
Sites / Locations
- Prosciento
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NGM313
Pioglitazone
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration
Secondary Outcome Measures
Full Information
NCT ID
NCT03298464
First Posted
September 22, 2017
Last Updated
March 11, 2019
Sponsor
NGM Biopharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03298464
Brief Title
Study of NGM313 in Obese Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
June 19, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NGM313
Arm Type
Experimental
Arm Title
Pioglitazone
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
NGM313
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
White to off-white round tablet
Primary Outcome Measure Information:
Title
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Prosciento
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of NGM313 in Obese Participants
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