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Study of NGM395 in Adult Participants

Primary Purpose

Obesity, NAFLD

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

NGM395

Placebo

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NGM Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Arm Label

NGM395 Dose 1

NGM395 Dose 2

NGM395 Dose 3

NGM395 Dose 4

NGM395 Dose 5

NGM395 Dose 6

Placebo

Arm Description

NGM395 Subcutaneous Injection

Placebo

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Serum Concentration of NGM395

NGM395 concentration data by cohort

Full Information

NCT ID

NCT04187339

First Posted

December 3, 2019

Last Updated

July 19, 2021

Sponsor

NGM Biopharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04187339

Brief Title

Study of NGM395 in Adult Participants

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).

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 13, 2020 (Actual)

Primary Completion Date

October 20, 2020 (Actual)

Study Completion Date

April 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NGM Biopharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Study of NGM395 in adult participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, NAFLD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NGM395 Dose 1

Arm Type

Experimental

Arm Description

NGM395 Subcutaneous Injection

Arm Title

NGM395 Dose 2

Arm Type

Experimental

Arm Description

NGM395 Subcutaneous Injection

Arm Title

NGM395 Dose 3

Arm Type

Experimental

Arm Description

NGM395 Subcutaneous Injection

Arm Title

NGM395 Dose 4

Arm Type

Experimental

Arm Description

NGM395 Subcutaneous Injection

Arm Title

NGM395 Dose 5

Arm Type

Experimental

Arm Description

NGM395 Subcutaneous Injection

Arm Title

NGM395 Dose 6

Arm Type

Experimental

Arm Description

NGM395 Subcutaneous Injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

NGM395

Intervention Description

NGM395 Dose 1

Intervention Type

Biological

Intervention Name(s)

NGM395

Intervention Description

NGM395 Dose 2

Intervention Type

Biological

Intervention Name(s)

NGM395

Intervention Description

NGM395 Dose 3

Intervention Type

Biological

Intervention Name(s)

NGM395

Intervention Description

NGM395 Dose 4

Intervention Type

Biological

Intervention Name(s)

NGM395

Intervention Description

NGM395 Dose 5

Intervention Type

Biological

Intervention Name(s)

NGM395

Intervention Description

NGM395 Dose 6

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

140 Days

Secondary Outcome Measure Information:

Title

Serum Concentration of NGM395

Description

NGM395 concentration data by cohort

Time Frame

140 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

NGM Study Director

Organizational Affiliation

NGM Biopharmaceuticals, Inc

Official's Role

Study Director

Facility Information:

Facility Name

NGM Clinical Study Site

City

Brisbane

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of NGM395 in Adult Participants

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