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Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NGM282
Placebo
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically confirmed NASH diagnosis as defined by the NASH CRN
  2. Total liver fat content of ≥ 8% as measured by MRI-PDFF

Exclusion Criteria:

  1. Clinically significant acute or chronic liver disease of an etiology other than NASH
  2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
  3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
  4. Prior or pending liver transplantation

Other protocol-defined inclusion/exclusion criteria could apply.

Sites / Locations

  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

NGM282 Dose 1

NGM282 Dose 2

NGM282 Dose 3

Placebo

Arm Description

Administered by subcutaneous injection

Administered by subcutaneous injection

Administered by subcutaneous injection

Administered by subcutaneous injection

Outcomes

Primary Outcome Measures

Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo.
Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2019
Last Updated
January 5, 2022
Sponsor
NGM Biopharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03912532
Brief Title
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
Official Title
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
March 29, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGM282 Dose 1
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Arm Title
NGM282 Dose 2
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Arm Title
NGM282 Dose 3
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
NGM282
Intervention Description
NGM282
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo for NGM282
Primary Outcome Measure Information:
Title
Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo.
Time Frame
24 weeks
Title
Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282.
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
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed NASH diagnosis as defined by the NASH CRN Total liver fat content of ≥ 8% as measured by MRI-PDFF Exclusion Criteria: Clinically significant acute or chronic liver disease of an etiology other than NASH Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters Prior or pending liver transplantation Other protocol-defined inclusion/exclusion criteria could apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NGM Study Director
Organizational Affiliation
NGM Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
NGM Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
NGM Clinical Study Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
NGM Clinical Study Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
NGM Clinical Study Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
NGM Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
NGM Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
NGM Clinical Study Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
NGM Clinical Study Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
NGM Clinical Study Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
NGM Clinical Study Site
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
NGM Clinical Study Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
NGM Clinical Study Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
NGM Clinical Study Site
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
NGM Clinical Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NGM Clinical Study Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
NGM Clinical Study Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
NGM Clinical Study Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
NGM Clinical Study Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
NGM Clinical Study Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
NGM Clinical Study Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
NGM Clinical Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
NGM Clinical Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NGM Clinical Study Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
NGM Clinical Study Site
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
NGM Clinical Study Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
NGM Clinical Study Site
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
NGM Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
NGM Clinical Study Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
NGM Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
NGM Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NGM Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
NGM Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
NGM Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
NGM Clinical Study Site
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35325622
Citation
Harrison SA, Abdelmalek MF, Neff G, Gunn N, Guy CD, Alkhouri N, Bashir MR, Freilich B, Kohli A, Khazanchi A, Sheikh MY, Leibowitz M, Rinella ME, Siddiqui MS, Kipnes M, Moussa SE, Younes ZH, Bansal M, Baum SJ, Borg B, Ruane PJ, Thuluvath PJ, Gottwald M, Khan M, Chen C, Melchor-Khan L, Chang W, DePaoli AM, Ling L, Lieu HD. Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):603-616. doi: 10.1016/S2468-1253(22)00017-6. Epub 2022 Mar 21.
Results Reference
derived

Learn more about this trial

Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

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