A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH

NASH - Nonalcoholic Steatohepatitis Clinical Trial

— VOYAGE  

Official title:

VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04173065
• Other study ID #: VK2809-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 15, 2019
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Viking Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: June 2024
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate;

2. Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during

screening or within 6 months before screening; for this study, confirmation requires:

1. NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and

2. NASH activity score (NAS) of =4 with at least a score of 1 in each of the following NAS components: ballooning degeneration (score = 0-2), lobular inflammation (score = 0-3) and steatosis (score = 0-3); (c) F1 subjects must have at least one of these risk factors: type 2 diabetes, body mass index of = 30 mg/ m2, and/ or alanine aminotransferase > 1.5 x ULN

3. Have a screening MRI-PDFF with = 8% liver fat fraction;

4. Male and females be 18 to 75 years of age, inclusive, at screening;

Exclusion Criteria:

1. Are unwilling to undergo the required liver biopsy procedures or have any condition that would prevent obtaining a liver biopsy as part of this clinical protocol

2. Have evidence of current or history of excessive alcohol consumption of more than 20 g per day for women and 30 g per day for men, on average, within 6 months before the qualifying liver biopsy and up to randomization, or are unable to provide a reliable estimate of alcohol consumption during this period;

3. Treatment with medications for the purpose of weight loss within 6 months prior to qualifying liver biopsy, unless approved after consultation with the medical monitor. These include drugs approved for weight loss (e.g. orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as drugs used off-label, herbal preparations and dietary supplements marketed for control of body weight or appetite;

4. TSH outside central laboratory reference range;

5. Free T4 outside central laboratory reference range;

6. Cardiac troponin I (cTnI) and creatine kinase MB isoenzyme (CK-MB) > Upper Limit of Normal (ULN) at screening;

7. Serum albumin < 3.5 g/dL;

8. International normalized ratio (INR) > 1.3;

9. Total bilirubin > 1.2 X ULN (except in presence of Gilbert synd

10. Strong or moderate inhibitors or inducers of CYP3A4 are prohibited during the study period

11. Drugs that may affect liver fat content or are associated with nonalcoholic fatty liver disease (NAFLD) are prohibited during the 3 month period prior to the baseline liver biopsy and up to the end of treatment

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• VK2809
Capsule
• Placebos
Capsule

Locations

Country	Name	City	State
Belgium	Viking Clinical Site 502	Brussels
Belgium	Viking Clinical Site 503	Brussels	VBR
France	Viking Clinical Site 611	Amiens Cedex 1
France	Viking Clinical Site 612	Créteil
France	Viking Clinical Site 610	Grenoble
France	Viking Clinical Site 603	Paris
France	Viking Clinical Site 607	Paris
Mexico	Viking Clinical Site 401	Acapulco	GRO
Mexico	Viking Clinical Site 421	Ciudad de mexico
Mexico	Viking Clinical Site 422	Monterrey	NLE
Puerto Rico	Viking Clinical Site 219	San Juan
United States	Viking Clinical Site 158	Ann Arbor	Michigan
United States	Viking Clinical Site 115	Arlington	Texas
United States	Viking Clinical Site 144	Atlanta	Georgia
United States	Viking Clinical Site 109	Baltimore	Maryland
United States	Viking Clinical Site 147	Boston	Massachusetts
United States	Viking Clinical Site 226	Bradenton	Florida
United States	Viking Clinical Site 314	Chapel Hill	North Carolina
United States	Viking Clinical Site 137	Cincinnati	Ohio
United States	Viking Clinical Site 227	Clarksville	Tennessee
United States	Viking Clinical Site 126	Concord	North Carolina
United States	Viking Clinical Site 113	Dallas	Texas
United States	Viking Clinical Site 133	Detroit	Michigan
United States	Viking Clinical Site 116	Durham	North Carolina
United States	Viking Clinical Site 220	Edinburg	Texas
United States	Viking Clinical Site 161	Fresno	California
United States	Viking Clinical Site 208	Fresno	California
United States	Viking Clinical Site 216	Glendale	Arizona
United States	Viking Clinical Site 107	Greenbelt	Maryland
United States	Viking Clinical Site 127	Greenville	South Carolina
United States	Viking Clinical Site 118	Hermitage	Tennessee
United States	Viking Clinical Site 142	Houston	Texas
United States	Viking Clinical Site 120	Indianapolis	Indiana
United States	Viking Clinical Site 213	Jackson	Mississippi
United States	Viking Clinical Site 112	Kansas City	Missouri
United States	Viking Clinical Site 217	Kansas City	Missouri
United States	Viking Clinical Site 302	La Jolla	California
United States	Viking Clinical Site 150	Lakewood Ranch	Florida
United States	Viking Clinical Site 160	Las Vegas	Nevada
United States	Viking Clinical Site 105	Madison	Alabama
United States	Viking Clinical Site 111	Marietta	Georgia
United States	Viking Clinical Site 146	Marrero	Louisiana
United States	Viking Clinical Site 106	Miami	Florida
United States	Viking Clinical Site 301	Miami	Florida
United States	Viking Clinical Site 310	Miami	Florida
United States	Viking Clinical Site 221	Miami Lakes	Florida
United States	Viking Clinical Site 134	Montclair	California
United States	Viking Clinical Site 153	Morehead City	North Carolina
United States	Viking Clinical Site 156	New Haven	Connecticut
United States	Viking Clinical Site 307	New Orleans	Louisiana
United States	Viking Clinical Site 152	New York	New York
United States	Viking Clinical Site 304	Newport News	Virginia
United States	Viking Clinical Site 214	North Little Rock	Arkansas
United States	Viking Clinical Site 224	Ogden	Utah
United States	Viking Clinical Site 205	Panorama City	California
United States	Viking Clinical Site 125	Pasadena	California
United States	Viking Clinical Site 131	Pensacola	Florida
United States	Viking Clinical Site 148	Philadelphia	Pennsylvania
United States	Viking Clinical Site 311	Pittsburgh	Pennsylvania
United States	Viking Clinical Site 215	Port Orange	Florida
United States	Viking Clinical Site 223	Reno	Nevada
United States	Viking Clinical Site 110	Rialto	California
United States	Viking Clinical Site 209	Richmond	Virginia
United States	Viking Clinical Site 312	Richmond	Virginia
United States	Viking Clinical Site 128	Rochester	New York
United States	Viking Clinical Site 117	Sacramento	California
United States	Viking Clinical Site 101	San Antonio	Texas
United States	Viking Clinical Site 102	San Antonio	Texas
United States	Viking Clinical Site 143	San Antonio	Texas
United States	Viking Clinical Site 201	San Antonio	Texas
United States	Viking Clinical Site 121	San Diego	California
United States	Viking Clinical Site 103	San Francisco	California
United States	Viking Clinical Site 218	Sarasota	Florida
United States	Viking Clinical Site 317	Seattle	Washington
United States	Viking Clinical Site 130	South Bend	Indiana
United States	Viking Clinical Site 145	Topeka	Kansas
United States	Viking Clinical Site 159	Tucson	Arizona
United States	Viking Clinical Site 211	West Des Moines	Iowa
United States	Viking Clinical Site 166	West Monroe	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Viking Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Fat	Relative change in liver fat content (assessed by MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809 compared to the change in subjects treated with placebo.	12 weeks
Secondary	NASH CRN fibrosis score	Proportion of subjects with resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score.	52 weeks