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Study of NGM313 in Obese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298464
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Obese Biological: NGM313 Drug: Pioglitazone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NGM313 Biological: NGM313
Subcutaneous injection

Active Comparator: Pioglitazone Drug: Pioglitazone
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Primary Outcome Measures :
  1. Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration [ Time Frame: 28 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298464


Locations
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United States, California
Prosciento
Chula Vista, California, United States, 91911
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03298464    
Other Study ID Numbers: 17-0202
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs