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OpenTrials
Completed

NCT Number: NCT04187339

Study of NGM395 in Adult Participants

Study of NGM395 in adult participants.

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Liver Diseases NAFLD Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NGM Clinical Study Site

Brisbane, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Part 1:

  • Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.

Part 2:

  • Liver fat ≥8% as assessed by MRI-PDFF.
  • BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
  • Waist circumference > 40 inches for males or > 35 inches for females.

Exclusion criteria

Part 1:

  • Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
  • Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
  • History of bariatric surgery.
  • Fasting triglycerides > 400 mg/dL at Screening.

Part 2:

  • Diagnosed with type 2 diabetes with a HbA1c >9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.

Treatment and study plan

NGM395

Biological

NGM395 Dose 1

Placebo

Other

Placebo

Primary outcomes

  1. Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 140 Days

    The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.

Secondary outcomes

  1. Serum Concentration of NGM395

    Time frame: 140 Days

    NGM395 concentration data by cohort

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 5, 2019
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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