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A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

NCT03551522•Gilead Sciences

View on ClinicalTrials.gov

Summary

A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed due to the early termination of the study

Detailed Description

Primary Objectives 1. To evaluate the effect of seladelpar on hepatic fat fraction, as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12 in the DB phase 2. To evaluate the safety and tolerability of seladelpar in the DB and OLE phases Secondary Objectives 1. To evaluate the effect of seladelpar on MRI- PDFF at Week 26 and Week 52 in the DB phase 2. To evaluate the effect of seladelpar on histological improvement of nonalcoholic fatty liver disease activity score (NAS) at Week 52 in the DB phase 3. To evaluate the effect of seladelpar on histological improvement of fibrosis at Week 52 in the DB phase 4. To evaluate the effect of seladelpar on metabolic biochemical markers and biochemical markers of inflammation in the DB and OLE phases

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must be able to provide written informed consent (signed and dated) and any authorizations required by local law
•2. 18 to 75 years old (inclusive)
•3. Histological evidence of definite NASH on a liver biopsy (obtained during the screening period or historical liver biopsy obtained no more than 90 days prior to the initial screening visit)
•4. NAS of 4 points or greater with a score of at least 1 point in each component (steatosis, lobular inflammation, and ballooning)
•5. Fibrosis stage 1, 2, or 3 on liver biopsy
•6. MRI-PDFF ≥ 10%
•7. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 30 days after the last dose of study drug. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose of study drug.

Exclusion Criteria

•1. Significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to reliably quantify alcohol intake
•2. Treatment with drugs associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, oral glucocorticoids at doses greater than 5 mg/day, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids (such as testosterone and valproic acid) for more than 4 weeks within the last 2 months prior to the initial screening
•3. Treatment with pioglitazone or high-dose vitamin E (\>400 IU/day) within the last 2 months prior to the initial screening
•4. Initiation of treatment with a glucagon-like peptide-1 (GLP-1) agonist or a dose change within the last 2 months prior to the initial screening
•5. Prior or planned bariatric surgery (a prior reversed sleeve gastrectomy is permitted)
•6. Poorly controlled type 2 diabetes mellitus as defined by hemoglobin A1c \[HbA1c\] 9.5% or higher or type 1 diabetes mellitus
•7. Diabetic patients who are taking sodium/glucose cotransporter 2 (SGLT-2) inhibitors must be on a stable dose within 2 months prior to the initial screening and throughout the study
•8. Significant weight loss within the last 6 months (e.g., \> 10%)
•9. Use of any weight-loss medication for 3 months prior to and during the study period
•10. Body mass index (BMI) \< 18.5 kg/m2
+44 more criteria

Locations (14)

CymaBay Research Site

Glendale, Arizona, United States

CymaBay Research Site

Tucson, Arizona, United States

CymaBay Research Site

Los Angeles, California, United States

CymaBay Research Site

Boca Raton, Florida, United States

CymaBay Research Site

Lakewood Rch, Florida, United States

CymaBay Research Site

Flowood, Mississippi, United States

CymaBay Research Site

Clarksville, Tennessee, United States

CymaBay Research Site

Germantown, Tennessee, United States

CymaBay Research Site

Hermitage, Tennessee, United States

CymaBay Research Site

Knoxville, Tennessee, United States

Key Dates

Start Date

April 30, 2018

Primary Completion Date

May 8, 2019

Completion Date

August 10, 2020

Last Updated

September 15, 2022

Enrollment

181

ACTUAL participants

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

Seladelpar

DRUG

Placebos

DRUG

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

NCT03587831

NASH - Nonalcoholic Steatohepatitis

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ACTIVE_NOT_RECRUITINGNA

Hepatic Energy Fluxes in NASH and NAS Patients

NCT03997422

NASH - Nonalcoholic SteatohepatitisNAS+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Inclusion Criteria

Exclusion Criteria

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Hepatic Energy Fluxes in NASH and NAS Patients

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