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).

Study of NGM395 in adult participants.

Study Overview

• Status: Completed
• Conditions: Obesity; NAFLD
• Intervention / Treatment: Other: Placebo; Biological: NGM395; Biological: NGM395; Biological: NGM395; Biological: NGM395; Biological: NGM395; Biological: NGM395

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • NGM Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: NGM395 Dose 1; NGM395 Subcutaneous Injection	Biological: NGM395; NGM395 Dose 1; Biological: NGM395; NGM395 Dose 2; Biological: NGM395; NGM395 Dose 3; Biological: NGM395; NGM395 Dose 4; Biological: NGM395; NGM395 Dose 5; Biological: NGM395; NGM395 Dose 6
Experimental: NGM395 Dose 2; NGM395 Subcutaneous Injection	Biological: NGM395; NGM395 Dose 1; Biological: NGM395; NGM395 Dose 2; Biological: NGM395; NGM395 Dose 3; Biological: NGM395; NGM395 Dose 4; Biological: NGM395; NGM395 Dose 5; Biological: NGM395; NGM395 Dose 6
Experimental: NGM395 Dose 3; NGM395 Subcutaneous Injection	Biological: NGM395; NGM395 Dose 1; Biological: NGM395; NGM395 Dose 2; Biological: NGM395; NGM395 Dose 3; Biological: NGM395; NGM395 Dose 4; Biological: NGM395; NGM395 Dose 5; Biological: NGM395; NGM395 Dose 6
Experimental: NGM395 Dose 4; NGM395 Subcutaneous Injection	Biological: NGM395; NGM395 Dose 1; Biological: NGM395; NGM395 Dose 2; Biological: NGM395; NGM395 Dose 3; Biological: NGM395; NGM395 Dose 4; Biological: NGM395; NGM395 Dose 5; Biological: NGM395; NGM395 Dose 6
Experimental: NGM395 Dose 5; NGM395 Subcutaneous Injection	Biological: NGM395; NGM395 Dose 1; Biological: NGM395; NGM395 Dose 2; Biological: NGM395; NGM395 Dose 3; Biological: NGM395; NGM395 Dose 4; Biological: NGM395; NGM395 Dose 5; Biological: NGM395; NGM395 Dose 6
Experimental: NGM395 Dose 6; NGM395 Subcutaneous Injection	Biological: NGM395; NGM395 Dose 1; Biological: NGM395; NGM395 Dose 2; Biological: NGM395; NGM395 Dose 3; Biological: NGM395; NGM395 Dose 4; Biological: NGM395; NGM395 Dose 5; Biological: NGM395; NGM395 Dose 6

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): April 22, 2021

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NGM395-OB-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No