Study of NGM313 in Obese Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03298464

Enrollment

Registered

2017-10-02

Start date

2017-09-11

Completion date

2018-07-17

Last updated

2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese

Brief summary

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

Interventions

BIOLOGICALNGM313

Subcutaneous injection

DRUGPioglitazone

White to off-white round tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration	28 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026