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Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

NGM282

Placebo

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females, between 18 and 75 years of age, inclusive
Histologically confirmed NASH diagnosis

Exclusion Criteria:

Clinically significant acute or chronic liver disease
Prior liver transplantation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Cohort 1 - Placebo

Cohort 1 - NGM282 3mg

Cohort 1 - NGM282 6mg

Cohort 2 - NGM282 0.3mg

Cohort 2 - NGM282 1mg

Cohort 2 - NGM282 3mg

Cohort 3 - NGM282 1mg

Cohort 4 - Placebo

Cohort 4 - NGM282 1mg

Arm Description

Cohort 1 - Placebo

Cohort 1 - NGM282 3mg

Cohort 1 - NGM282 6mg

Cohort 2 - NGM282 0.3mg

Cohort 2 - NGM282 1mg

Cohort 2 - NGM282 3mg

Cohort 3 - NGM282 1mg

Cohort 4 - Placebo

Cohort 4 - NGM282 1mg

Outcomes

Primary Outcome Measures

Change in absolute liver fat content as measured by MRI from Baseline to Week 24

Secondary Outcome Measures

Change in percentage liver fat content as measure by MRI from Baseline to Week 24

Full Information

NCT ID

NCT02443116

First Posted

May 11, 2015

Last Updated

September 9, 2020

Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

NGM Biopharmaceuticals Australia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02443116

Brief Title

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Multiple-center Study With Additional Open-label Single-blind and Placebo-controlled 24-Week Histology Cohorts to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for Up to 24 Weeks in Patients With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 31, 2015 (Actual)

Primary Completion Date

December 6, 2019 (Actual)

Study Completion Date

January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

NGM Biopharmaceuticals Australia Pty Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

6. Conditions and Keywords

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

Nonalcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 - Placebo

Arm Type

Placebo Comparator

Arm Description

Cohort 1 - Placebo

Arm Title

Cohort 1 - NGM282 3mg

Arm Type

Experimental

Arm Description

Cohort 1 - NGM282 3mg

Arm Title

Cohort 1 - NGM282 6mg

Arm Type

Experimental

Arm Description

Cohort 1 - NGM282 6mg

Arm Title

Cohort 2 - NGM282 0.3mg

Arm Type

Experimental

Arm Description

Cohort 2 - NGM282 0.3mg

Arm Title

Cohort 2 - NGM282 1mg

Arm Type

Placebo Comparator

Arm Description

Cohort 2 - NGM282 1mg

Arm Title

Cohort 2 - NGM282 3mg

Arm Type

Experimental

Arm Description

Cohort 2 - NGM282 3mg

Arm Title

Cohort 3 - NGM282 1mg

Arm Type

Experimental

Arm Description

Cohort 3 - NGM282 1mg

Arm Title

Cohort 4 - Placebo

Arm Type

Placebo Comparator

Arm Description

Cohort 4 - Placebo

Arm Title

Cohort 4 - NGM282 1mg

Arm Type

Experimental

Arm Description

Cohort 4 - NGM282 1mg

Intervention Type

Biological

Intervention Name(s)

NGM282

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in absolute liver fat content as measured by MRI from Baseline to Week 24

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change in percentage liver fat content as measure by MRI from Baseline to Week 24

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females, between 18 and 75 years of age, inclusive Histologically confirmed NASH diagnosis Exclusion Criteria: Clinically significant acute or chronic liver disease Prior liver transplantation

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 922

City

Chandler

State/Province

Arizona

Country

United States

Facility Name

NGM Clinical Study Site 923

City

Tucson

State/Province

Arizona

Country

United States

Facility Name

NGM Clinical Study Site 924

City

Los Angeles

State/Province

California

Country

United States

Facility Name

NGM Clinical Study Site 901

City

San Diego

State/Province

California

Country

United States

Facility Name

NGM Clinical Study Site 902

City

Denver

State/Province

Colorado

Country

United States

Facility Name

NGM Clinical Study Site 917

City

Lakewood Ranch

State/Province

Florida

Country

United States

Facility Name

NGM Clinical Study Site 906

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

NGM Clinical Study Site 918

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

NGM Clinical Study Site 903

City

Durham

State/Province

North Carolina

Country

United States

Facility Name

NGM Clinical Study Site 921

City

Germantown

State/Province

Tennessee

Country

United States

Facility Name

NGM Clinical Study Site 910

City

Dallas

State/Province

Texas

Country

United States

Facility Name

NGM Clinical Study Site 920

City

Rollingwood

State/Province

Texas

Country

United States

Facility Name

NGM Clinical Study Site 905

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

NGM Clinical Study Site 909

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

NGM Clinical Study Site 904

City

Charlottesville

State/Province

Virginia

Country

United States

Facility Name

NGM Clinical Study Site 911

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

NGM Clinical Study Site 908

City

Seattle

State/Province

Washington

Country

United States

Facility Name

NGM Clinical Study Site 703

City

Sydney

State/Province

New South Wales

Country

Australia

Facility Name

NGM Clinical Study Site 704

City

Adelaide

State/Province

South Australia

Country

Australia

Facility Name

NGM Clinical Study Site 701

City

Melbourne

State/Province

Victoria

Country

Australia

Facility Name

NGM Clinical Study Site 705

City

Melbourne

State/Province

Victoria

Country

Australia

Facility Name

NGM Clinical Study Site 916

City

San Juan

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

33898959

Citation

Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.

Results Reference

derived

PubMed Identifier

32794259

Citation

Loomba R, Ling L, Dinh DM, DePaoli AM, Lieu HD, Harrison SA, Sanyal AJ. The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. Hepatology. 2021 Jan;73(1):126-143. doi: 10.1002/hep.31523. Epub 2020 Dec 11.

Results Reference

derived

PubMed Identifier

32781086

Citation

Harrison SA, Neff G, Guy CD, Bashir MR, Paredes AH, Frias JP, Younes Z, Trotter JF, Gunn NT, Moussa SE, Kohli A, Nelson K, Gottwald M, Chang WCG, Yan AZ, DePaoli AM, Ling L, Lieu HD. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Jan;160(1):219-231.e1. doi: 10.1053/j.gastro.2020.08.004. Epub 2020 Aug 8.

Results Reference

derived

PubMed Identifier

29519502

Citation

Harrison SA, Rinella ME, Abdelmalek MF, Trotter JF, Paredes AH, Arnold HL, Kugelmas M, Bashir MR, Jaros MJ, Ling L, Rossi SJ, DePaoli AM, Loomba R. NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2018 Mar 24;391(10126):1174-1185. doi: 10.1016/S0140-6736(18)30474-4. Epub 2018 Mar 5. Erratum In: Lancet. 2018 Mar 24;391(10126):e16.

Results Reference

derived

Learn more about this trial

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

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Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis (NASH)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial