Clinical Trials Logo
  1. Home
  2. Obese
  3. NCT03298464
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04105075 - COPD in Obese Patients
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Recruiting NCT05857150 - Exercise Response in Humans With Obesity
Completed NCT03532672 - Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity N/A
Completed NCT02618486 - The Effects of Obesity on Non Surgical Periodontal Therapy N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT01724502 - Mitochondrial Dysfunction in Diabetes N/A
Completed NCT01724515 - PGC-1 and Mitochondrial Dysfunction in Diabetes N/A
Active, not recruiting NCT01634204 - Efficacy of a Web-based Weight Loss Program Phase 2
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT01421589 - Growth Hormone Treatment on Phosphocreatine Recovery in Obesity N/A
Completed NCT03528304 - Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss N/A
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01726647 - Metabolism Associated With Abdominal Fat Mass Distribution N/A
Active, not recruiting NCT02125149 - The Expecting Study N/A
Completed NCT05737927 - Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects Phase 1
Completed NCT05433506 - Safety and Pharmacokinetics of HU6 Phase 1
Completed NCT02871882 - Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus Phase 2
Completed NCT05061173 - Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults N/A
Completed NCT02919176 - Brown Fat Activation Study Early Phase 1