Study of NGM395 in Adult Participants

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).

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04187339

Enrollment

Registered

2019-12-05

Start date

2020-02-13

Completion date

2021-04-22

Last updated

2021-07-21

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

Conditions

NAFLD, Obesity

Brief summary

Study of NGM395 in adult participants.

Interventions

BIOLOGICALNGM395

NGM395 Dose 1

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Part 1: 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: 2. Liver fat ≥8% as assessed by MRI-PDFF. 3. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening. 4. Waist circumference \> 40 inches for males or \> 35 inches for females.

Exclusion criteria

Part 1: 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. 2. Subjects with T2D managed with diet alone with HbA1c level \> 6.5% or fasting glucose ≥ 126 mg/dL at Screening. 3. History of bariatric surgery. 4. Fasting triglycerides \> 400 mg/dL at Screening. Part 2: 5. 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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)	140 Days	The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.

Secondary

Measure	Time frame	Description
Serum Concentration of NGM395	140 Days	NGM395 concentration data by cohort

Countries

Australia

Outcome results

None listed

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