JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

NCT02442687 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro00062677
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 8

Brief Summary

To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population)

  Baseline to week 24

• Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population)

  Baseline to Week 12

Secondary Outcomes (18)

• Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population)

  Baseline to week 24

• Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population)

  Baseline to week 12

• Time to Remission (in Weeks)

  24 weeks

• Change in BMI (Body Mass Index)

  Baseline, week 24

• Change in Hemoglobin A1C

  Baseline, week 24

Study Arms (3)

A

ACTIVE COMPARATOR

JKB 121, 5 mg twice daily

Drug: JKB-121: 5 mg twice daily

B

ACTIVE COMPARATOR

JKB 121, 10 mg twice daily

Drug: JKB-121: 10 mg twice daily

C

PLACEBO COMPARATOR

Identical appearing placebo

Drug: Placebo

Interventions

JKB-121: 10 mg twice daily DRUG

B

Placebo DRUG

C

JKB-121: 5 mg twice daily DRUG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Provision of written informed consent
• Biopsy-proven NASH within 12 months or at screening
• ALT \> 40 U/L for women and \> 60 U/L for men at screening and at least once in the previous 12 months.
• HBA1C of ≤ 9.0

You may not qualify if:

• Any chronic liver disease other than NASH
• Cirrhosis, as assessed clinically or histologically
• Presence of vascular liver disease
• BMI ≤ 25 kg/m2
• Excessive alcohol use (\> 20 g/day) within the past 2 years
• AST or ALT \> 250 U/L.
• Type 1 diabetes mellitus
• Bariatric surgery in the past 5 years.
• Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
• Contraindication to MRI
• Inadequate venous access
• HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C virus (HCV) RNA positive.
• Receiving an elemental diet or parenteral nutrition
• Chronic pancreatitis or pancreatic insufficiency
• Any history of complications of cirrhosis

Sponsors & Collaborators

• Manal Abdelmalek: lead

Study Sites (8)

Digestive Disease Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Digestive Associates

Las Vegas, Nevada, 89102, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Digestive Disease Specialists

Cincinnati, Ohio, 45219, United States

Location

Brook Army Medical Center

Houston, Texas, 78234, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22903, United States

Location

Medical College of Virginia

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.

  PMID: 36318027 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Limitations and Caveats

This is a pilot study to assess safety and tolerability of JKB 121 in patients with biopsy-proven NASH. There The study was underpowered to detect rare events.

Results Point of Contact

• Title: Dr. Manal F. Abdelmalek
• Organization: Duke University

manal.abdelmalek@duke.edu

919-684-8356

Study Officials

• Manal F Abdelmalek, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: May 13, 2015
• Study Start: August 1, 2015
• Primary Completion: September 24, 2017
• Study Completion: September 24, 2017
• Last Updated: January 7, 2019
• Results First Posted: January 7, 2019

Record last verified: 2018-12

Locations

US (8)