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Harmony: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Sponsor
Akero Therapeutics, Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04767529
Collaborator
(none)
128
Enrollment
54
Locations
3
Arms
38.4
Anticipated Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date :
Feb 16, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: EFX 28 mg

Drug: EFX
Administered by subcutaneous injection
Experimental: EFX 50 mg

Drug: EFX
Administered by subcutaneous injection
Placebo Comparator: Placebo

Drug: Placebo
Administered by subcutaneous injection

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system [24 Weeks]

Secondary Outcome Measures

  1. Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system [24 Weeks, 96 Weeks]

  2. Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system [96 Weeks]

  3. Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score [24 Weeks, 96 Weeks]

  4. Change from baseline in hepatic fat fraction [24 Weeks, 96 Weeks]

  5. Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C [24 Weeks, 48 Weeks, 96 Weeks]

  6. Change from baseline of markers of glycemic control - HbA1c [24 Weeks, 48 Weeks, 96 Weeks]

  7. Change from baseline of markers of glycemic control - C-Peptide [24 Weeks, 48 Weeks, 96 Weeks]

  8. Change from baseline of markers of glycemic control - Adiponectin [24 Weeks, 48 Weeks, 96 Weeks]

  9. Change from baseline of markers of glycemic control - HOMA-IR [24 Weeks, 48 Weeks, 96 Weeks]

  10. Change from baseline of non-invasive fibrosis biomarkers - ELF [24 Weeks, 48 Weeks, 96 Weeks]

  11. Change from baseline of non-invasive fibrosis biomarkers - Pro-C3 [24 Weeks, 48 Weeks, 96 Weeks]

  12. Change from baseline of non-invasive fibrosis biomarkers - NIS-4 [24 Weeks, 48 Weeks, 96 Weeks]

  13. Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®) [24 Weeks, 48 Weeks, 96 Weeks]

  14. Change from baseline of body weight [24 Weeks, 48 Weeks, 96 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Males and non-pregnant, non-lactating females between 18 - 75 years of age inclusive, based on the date of the screening visit.

  • Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.

  • FibroScan® measurement > 8.5 kPa.

  • Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

  • Steatosis (scored 0 to 3),

  • Ballooning degeneration (scored 0 to 2), and

  • Lobular inflammation (scored 0 to 3).

Exclusion Criteria:

  • Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.

  • Presence of cirrhosis on liver biopsy (stage 4 fibrosis).

  • Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akero Clinical Study Site Chandler Arizona United States 85224
2 Akero Clinical Study Site Glendale Arizona United States 85304
3 Akero Clinical Study Site Tucson Arizona United States 85712
4 Akero Clinical Study Site North Little Rock Arkansas United States 72117
5 Akero Clinical Study Site Chula Vista California United States 91910
6 Akero Clinical Study Site Fresno California United States 93720
7 Akero Clinical Study Site La Jolla California United States 92037
8 Akero Clinical Study Site Los Angeles California United States 90036
9 Akero Clinical Study Site Los Angeles California United States 90048
10 Akero Clinical Study Site Los Angeles California United States 90057
11 Akero Clinical Study Site Orange California United States 92866
12 Akero Clinical Study Site Rialto California United States 92866
13 Akero Clinical Study Site Santa Ana California United States 92704
14 Akero Clinical Study Site Fort Myers Florida United States 33912
15 Akero Clinical Study Site Inverness Florida United States 34452
16 Akero Clinical Study Site Lakewood Ranch Florida United States 34211
17 Akero Clinical Study Site Miami Lakes Florida United States 33016
18 Akero Clinical Study Site Miami Florida United States 33134
19 Akero Clinical Study Site Miami Florida United States 33147
20 Akero Clinical Study Site Ocala Florida United States 34471
21 Akero Clinical Study Site Sarasota Florida United States 94240
22 Akero Clinical Study Site Marietta Georgia United States 30060
23 Akero Clinical Study Site Topeka Kansas United States 66606
24 Akero Clinical Study Site Baton Rouge Louisiana United States 70809
25 Akero Clinical Study Site Marrero Louisiana United States 70072
26 Akero Clinical Study Site Ypsilanti Michigan United States 48197
27 Akero Clinical Study Site Flowood Mississippi United States 39232
28 Akero Clinical Study Site Jackson Mississippi United States 39216
29 Akero Clinical Study Site Las Vegas Nevada United States 89106
30 Akero Clinical Study Site Charlotte North Carolina United States 28204
31 Akero Clinical Study Site Durham North Carolina United States 27712
32 Akero Clinical Study Site Morehead City North Carolina United States 28557
33 Akero Clinical Study Site Cincinnati Ohio United States 45219
34 Akero Clinical Study Site Greenville South Carolina United States 29605
35 Akero Clinical Study Site Hermitage Tennessee United States 37076
36 Akero Clinical Study Site Nashville Tennessee United States 37211
37 Akero Clinical Study Site Arlington Texas United States 76012
38 Akero Clinical Study Site Austin Texas United States 78757
39 Akero Clinical Study Site Cedar Park Texas United States 75246
40 Akero Clinical Study Site Dallas Texas United States 75234
41 Akero Clinical Study Site Dallas Texas United States 75246
42 Akero Clinical Study Site Edinburg Texas United States 78539
43 Akero Clinical Study Site Fort Worth Texas United States 76104
44 Akero Clinical Study Site Garland Texas United States 75044
45 Akero Clinical Study Site Houston Texas United States 77058
46 Akero Clinical Study Site San Antonio Texas United States 78209
47 Akero Clinical Study Site San Antonio Texas United States 78215
48 Akero Clinical Study Site San Antonio Texas United States 78229
49 Akero Clinical Study Site San Marcos Texas United States 78666
50 Akero Clinical Study Site Webster Texas United States 77598
51 Akero Clinical Study Site Charlottesville Virginia United States 22908
52 Akero Clinical Study Site Richmond Virginia United States 23249
53 Akero Clinical Study Site Richmond Virginia United States 23298
54 Akero Clinical Study Site San Juan Puerto Rico 927

Sponsors and Collaborators

  • Akero Therapeutics, Inc

Investigators

  • Study Director: Akero Study Director, Study Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akero Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT04767529
Other Study ID Numbers:
  • AK-US-001-0102
First Posted:
Feb 23, 2021
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jun 8, 2022