Nonalcoholic Steatohepatitis (NASH)Phase 2NCT03823703

Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)

A Phase 2 study testing Miricorilant in people with Nonalcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 15 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nonalcoholic Steatohepatitis (NASH)
What is being tested?: Miricorilant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 15 sitesUnited States
Study dates: 4 Nov 2020to 5 Apr 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of NASH based on a biopsy obtained within the last year OR
Have a diagnosis of presumed NASH based on blood tests and scans

Who cannot join

Have participated in another clinical trial within the last year and received active treatment for NASH
Have participated in another clinical trial for any other indication within the last 3 months
Are pregnant or lactating women
Have a BMI <18 kg/m^2
Have had liver transplantation or plan to have liver transplantation during the study
Have type 1 diabetes or poorly controlled type 2 diabetes.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Site 211
Austin, Texas, 78757
Site 207
Chandler, Arizona, 85224
Site 232
East Syracuse, New York, 13057
Site 213
Edinburg, Texas, 78539
Site 215
Edinburg, Texas, 78539
Site 208
Glendale, Arizona, 85306
Site 228
Kansas City, Missouri, 61434
Site 227
Los Angeles, California, 90057
Site 214
Panorama City, California, 91402
Site 234
Port Orange, Florida, 32127
Site 212
San Antonio, Texas, 78229
Site 233
Santa Ana, California, 92704
Site 210
Sarasota, Florida, 34240
Site 226
Seattle, Washington, 98105
Site 209
Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).

Read the detailed description

This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.

Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.

Conditions: Nonalcoholic Steatohepatitis (NASH)
Being tested: Miricorilant, Placebo
Keywords: Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MiricorilantDrug
Also called CORT118335
Tablets taken orally
PlaceboDrug
Placebo tablets

Study groups in NCT03823703
Study group	Role	What they receive
Miricorilant- 900 mg	Experimental	Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily. Receives: Drug: Miricorilant
Miricorilant- 600 mg	Experimental	Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily. Receives: Drug: Miricorilant; Drug: Placebo
Placebo	Placebo comparator	Participants received 6 placebo tablets orally once daily. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and up to ~Day 95

Secondary outcomes (6)

Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of <30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and up to ~Day 95
Change From Baseline in Aspartate Aminotransferase
The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and Week 6
Change From Baseline in Alanine Aminotransferase
The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and Week 6
Change From Baseline in Gamma-glutamyl Transferase
The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and Week 6
Change From Baseline in Propeptide of Type III Collagen
The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and Week 6
Change From Baseline in Enhanced Liver Fibrosis Score
The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 20205 Apr 2021

First posted30 Jan 2019
Study start4 Nov 2020
Primary completion5 Apr 2021
Study completion5 Apr 2021

Why it stopped: Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03823703
Sponsor's protocol ID: CORT118335-860
Status last verified: Apr 2021
First submitted: 14 Jan 2019
Last updated: 31 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nonalcoholic Steatohepatitis (NASH) trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT03823703
Acronym / sponsor ID: CORT118335-860
Conditions: Nonalcoholic Steatohepatitis (NASH)
Keywords: Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH
Enrolment: 12 participants (actual)
Lead sponsor: Corcept TherapeuticsIndustry (pharma, biotech, devices)
Study start: 4 Nov 2020 (actual)
Primary completion: 5 Apr 2021 (actual)
Study completion: 5 Apr 2021 (actual)
First posted: 30 Jan 2019 (actual)
Results: Posted 31 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).

Detailed description

Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Miricorilant- 900 mg	Experimental	Drug: MiricorilantParticipants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
Miricorilant- 600 mg	Experimental	Drug: Miricorilant, Drug: PlaceboParticipants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
Placebo	Placebo comparator	Drug: PlaceboParticipants received 6 placebo tablets orally once daily.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Have a diagnosis of NASH based on a biopsy obtained within the last year OR
Have a diagnosis of presumed NASH based on blood tests and scans

Key exclusion criteria (6 listed)

Have participated in another clinical trial within the last year and received active treatment for NASH
Have participated in another clinical trial for any other indication within the last 3 months
Are pregnant or lactating women
Have a BMI <18 kg/m^2
Have had liver transplantation or plan to have liver transplantation during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiricorilantAlso: CORT118335Tablets taken orally	Drug	Miricorilant- 600 mg, Miricorilant- 900 mg
PlaceboPlacebo tablets	Drug	Miricorilant- 600 mg, Placebo

Primary outcome

Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
Time frame: Baseline and up to ~Day 95
The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

6 secondary outcomes

Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
Time frame: Baseline and up to ~Day 95
Change From Baseline in Aspartate Aminotransferase
Time frame: Baseline and Week 6
Change From Baseline in Alanine Aminotransferase
Time frame: Baseline and Week 6
Change From Baseline in Gamma-glutamyl Transferase
Time frame: Baseline and Week 6
Change From Baseline in Propeptide of Type III Collagen
Time frame: Baseline and Week 6
Change From Baseline in Enhanced Liver Fibrosis Score
Time frame: Baseline and Week 6

Results and safety

Results posted to the registry on 31 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Miricorilant- 900 mg	3	0
Miricorilant- 600 mg	5	0
Placebo	4	0

Primary outcome: Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction

Time frame: Baseline and up to ~Day 95. Mean (Standard Deviation). Unit: Percent change

Measure	Miricorilant- 900 mg n = 3	Miricorilant- 600 mg n = 2	Placebo n = 2
Value	-50.28 (13.723)	-22.94 (71.943)	4.63 (5.232)

Population analysed: The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Miricorilant- 900 mg	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Miricorilant- 600 mg	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Placebo	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): Due to observations related to safety, the study was terminated by the Sponsor prior to completion. The sample size at the time of study termination did not support formal tests to assess statistical differences between treatment groups, and therefore, no efficacy analyses specified in the protocol were performed. Descriptive statistics for efficacy endpoints are provided, but since no patient reached the Week 12 visit, and therefore, descriptive statistics at Week 12 are not presented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Director study director

Corcept Therapeutics

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Miricorilant in people with Nonalcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (time frame: Baseline and up to ~Day 95). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03823703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.