NCT03298464

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

September 22, 2017

Last Update Submit

March 11, 2019

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

  • Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration

    28 Days

Study Arms (2)

NGM313

EXPERIMENTAL
Biological: NGM313

Pioglitazone

ACTIVE COMPARATOR
Drug: Pioglitazone

Interventions

NGM313BIOLOGICAL

Subcutaneous injection

NGM313
PioglitazoneDRUG

White to off-white round tablet

Pioglitazone

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) of 30-43 kg/m2
  • Waist circumference \> 40 inches in males or \> 30 inches in females
  • Normal ECG readings

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prosciento

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 2, 2017

Study Start

September 11, 2017

Primary Completion

June 19, 2018

Study Completion

July 17, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)