← Back to Search

Unknown

Miricorilant - Fluvoxamine/Miricorilant for Weight Gain

Phase 1
Waitlist Available
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to understand a written informed consent
Willing and able to comply with all study requirements including potential CYP 2C19 genotyping analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on days 1 and 10
Awards & highlights

Study Summary

This trial will study how a drug is processed in the body when taken with a common inhibitor. Participants will take the drug with and without the inhibitor & blood samples will be tested for safety.

Eligible Conditions
  • Weight Gain
  • Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on days 1 and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on days 1 and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf)
Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last)
Maximum observed plasma concentration of miricorilant (Cmax)
Secondary outcome measures
Number of participants with a clinically-significant laboratory test abnormality
Number of participants with a clinically-significant vital sign abnormality
Number of participants with one or more serious adverse events (SAEs)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Miricorilant - Fluvoxamine/MiricorilantExperimental Treatment2 Interventions
Participants will receive a single oral dose of miricorilant 600 mg on Days 1 and 10 and a single oral dose of fluvoxamine 50 mg on Days 4 to 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miricorilant
2021
Completed Phase 2
~150
Fluvoxamine
2020
Completed Phase 4
~3259230

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,354 Total Patients Enrolled
5 Trials studying Weight Gain
451 Patients Enrolled for Weight Gain
Joseph Custodio, PhDStudy DirectorCorcept Therapeutics
4 Previous Clinical Trials
154 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program consider applicants aged below 65?

"This clinical trial has determined that the minimum age for enrollment is 18 and the maximum age for participation is 60."

Answered by AI

Are new participants still being added to this research endeavor?

"The study is currently recruiting participants and has done so since January 24th of 2023. Clinicaltrials.gov was updated with this information as recently as the 25th of the same month."

Answered by AI

Has the FDA sanctioned Miricorilant - Fluvoxamine/Miricorilant?

"Miricorilant - Fluvoxamine/Miricorilant has a safety rating of 1 due to the small amount of existing data regarding both its efficacy and safety as it is currently in Phase I trial."

Answered by AI

Who would be the ideal participants for this research?

"To qualify for this clinical trial, applicants must have suffered from antipsychotic-induced weight gain, and also non-alcoholic steatohepatitis (NASH). Additionally, candidates should be aged between 18 and 60 years old. The goal is to recruit a total of 26 participants."

Answered by AI

What is the aggregate number of participants taking part in this research project?

"Affirmative. According to clinicaltrials.gov, this medical experiment is presently recruiting individuals, having been first posted on January 24th 2023 and most recently updated the following day. 26 volunteers need to be drawn from 1 centre for participation in the study."

Answered by AI
~12 spots leftby Mar 2025