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Study of NGM395 in Adult Participants

Sponsor
NGM Biopharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT04187339
Collaborator
(none)
38
Enrollment
1
Location
7
Arms
14.3
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study of NGM395 in adult participants.

Condition or Disease Intervention/Treatment Phase
  • Biological: NGM395
  • Biological: NGM395
  • Biological: NGM395
  • Biological: NGM395
  • Biological: NGM395
  • Biological: NGM395
  • Other: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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).
Actual Study Start Date :
Feb 13, 2020
Actual Primary Completion Date :
Oct 20, 2020
Actual Study Completion Date :
Apr 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: NGM395 Dose 1

NGM395 Subcutaneous Injection

Biological: NGM395
NGM395 Dose 1
Experimental: NGM395 Dose 2

NGM395 Subcutaneous Injection

Biological: NGM395
NGM395 Dose 2
Experimental: NGM395 Dose 3

NGM395 Subcutaneous Injection

Biological: NGM395
NGM395 Dose 3
Experimental: NGM395 Dose 4

NGM395 Subcutaneous Injection

Biological: NGM395
NGM395 Dose 4
Experimental: NGM395 Dose 5

NGM395 Subcutaneous Injection

Biological: NGM395
NGM395 Dose 5
Experimental: NGM395 Dose 6

NGM395 Subcutaneous Injection

Biological: NGM395
NGM395 Dose 6
Placebo Comparator: Placebo

Placebo

Other: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Serum Concentration of NGM395 [140 Days]

    NGM395 concentration data by cohort

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  1. Liver fat ≥8% as assessed by MRI-PDFF.

  2. BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.

  3. 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:
  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NGM Clinical Study Site Brisbane Australia

Sponsors and Collaborators

  • NGM Biopharmaceuticals, Inc

Investigators

  • Study Director: NGM Study Director, NGM Biopharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT04187339
Other Study ID Numbers:
  • NGM395-OB-101
First Posted:
Dec 5, 2019
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jul 21, 2021