Miricorilant for Schizophrenia

Phase-Based Estimates
1
Effectiveness
2
Safety
Site # 239, Garden Grove, CA
Schizophrenia+3 More
Miricorilant - Drug
Eligibility
18+
All Sexes
Eligible conditions
Schizophrenia

Study Summary

This study is evaluating whether a drug may help reduce weight in individuals with schizophrenia.

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Eligible Conditions

  • Schizophrenia
  • Manic Disorder
  • Weight Gain
  • Bipolar Disorder
  • Antipsychotic-induced Weight Gain (AIWG)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Miricorilant will improve 2 primary outcomes and 3 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of Up to Follow-up Visit (up to Week 16).

Week 12
Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo
Week 12
Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12
Percentage of patients achieving more than or equal to 5% weight loss
Week 12
Change from baseline in waist-to-hip ratio at Week 12
Week 16
Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo
CORT118335- 600 mg
Placebo group

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Miricorilant is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

CORT118335- 600 mg
Drug
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.
Placebo
Drug
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline day1 to week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline day1 to week 12 for reporting.

Closest Location

Site # 239 - Garden Grove, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Are able to successfully complete the placebo tablet swallow test. show original
This means that your BMI is greater than 30 kg/m2. show original
People who have schizophrenia or bipolar disorder are at an increased risk for suicide. show original
You are currently taking an oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications. show original
The person must have been on a stable dose of medication for one month prior to screening. show original

Patient Q&A Section

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

What are common treatments for schizophrenia?

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Data from a recent study adds to our growing knowledge of the common treatments used to manage schizophrenia. It also introduces a new area which requires more investigation: the use of the pharmaceutical industry for schizophrenia treatment.

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What are the signs of schizophrenia?

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The signs of schizophrenia consist of changes in perceptions, thoughts or mood. These may include experiencing mental slowness, changing the way people spend their free time, seeing people in the distance, or difficulty organizing conversations. There are also signs that involve a lack of motivation. These can include difficulties making choices, not finding the motivation to undertake an activity, and not having the energy to do jobs that require concentration. There are also signs of thinking problems, such as difficulty making judgments, having problems staying on task, poor reasoning, and problems remembering.

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What is schizophrenia?

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Schizophrenia and psychosis are two different conditions, though both have psychotic symptoms in common. Schizophrenia is a long-term mental illness that frequently resolves on its own, whereas psychosis is a chronic mental illness that can progress from one episode to another. The term 'psychosis' is often used to refer to either condition and thus can lead to misunderstanding. Schizophrenia is a neurological disorder that can affect brain functioning in many different ways. It can affect the thinking, behaviour, emotions and perception of the person diagnosed as schizophrenia. Schizophrenia, like bipolar disorder, may have an inherited component. It is believed to occur because of environmental factors or a combination between the environmental factors and an inherited vulnerability.

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Can schizophrenia be cured?

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Treatment for schizophrenia should take into account the high propensity for psychosis to respond to medication, so that there are potential benefits for the patient.

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What causes schizophrenia?

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Different factors may influence schizophrenia, including genetic and environmental factors. It is not clear what particular cause drives schizophrenia, however it is possible that both genetic factors and environmental causes are involved.

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How many people get schizophrenia a year in the United States?

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At least 180,000 Americans per year have schizophrenia. In the United States adolescents with a diagnosis of an affective disorder are 4.9% and 2.8% of those with a psychotic disorder. In a meta-analysis of 16 cohort studies in the US, the pooled prevalence of psychotic disorders in the general population was 5.3%. The incidence rate of psychotic disorders in the general population in the US is estimated at 1.6 new cases per thousand person-years. In a study of American adults the prevalence of psychotic disorders in the general population was 4.9%. In a cohort of elderly Americans study the lifetime prevalence of major depression was 28.8% with a lifetime prevalence rate of 1.

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Does miricorilant improve quality of life for those with schizophrenia?

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Miricorrant therapy using a selective DA D2 antagonist over 12 weeks in adults with stable schizophrenia is a safe and effective treatment that appears to reduce cognitive deficits in patients with schizophrenia. Miricorrant therapy significantly improved patients' QoL and may be an appropriate adjunctive therapy for those patients who do not respond to typical antipsychotic drugs and who have a poor QoL.

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What is the average age someone gets schizophrenia?

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I think the average has to be higher than I've said for multiple reasons, it's not the same all over the world, and I think it just starts to decline at around 40-50 years old because there are more options of treatment and they have more control over their medication. I prefer to refer to this age range as having to be diagnosed with schizophrenia.

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What are the latest developments in miricorilant for therapeutic use?

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Miricorilant showed promise in reducing aggression in a short-term study in persons with schizophrenia, regardless of prior medication. More rigorous studies that investigate the long-term efficacy and side effects of miricorilant are warranted.

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Have there been other clinical trials involving miricorilant?

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Although there have also been 3 randomized studies in adults and 4 retrospective studies in children, no randomized clinical trial has been performed. Further, a systematic review of all trials (published and unpublished) suggests that there is only poor evidence of efficacy, based on limited available data. This article is protected by copyright: all rights reserved.

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How does miricorilant work?

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Miricorlistimetic actions in humans may be mediated, at least in part, by the activation of the RhoA-Rho-kinase signaling pathway. The mechanism for this action may be mediated via the inhibition of the release of glutamate from synaptic vesicles.

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Who should consider clinical trials for schizophrenia?

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Patients and their doctors are concerned around the possibility that clinicians are receiving grants and payment for conducting trials. Patients and their doctors also wish to have the most evidence-informed decision made possible. The issue of receiving payment at the trial stage and for conducting the trials themselves does not seem to be of great concern to these patients and their doctors.

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