Antipsychotic-induced Weight Gain (AIWG)Phase 2GRATITUDENCT03818256
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
A Phase 2 study testing Miricorilant in people with Antipsychotic-induced Weight Gain (AIWG), run by Corcept Therapeutics at 27 sites in United States.
Trial summary
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with antipsychotic medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antipsychotic-induced Weight Gain (AIWG)
- 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
- 71 participants
- Where
- 27 sitesUnited States
- Study dates
- 4 Dec 2019to 6 Jul 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of schizophrenia or bipolar disorder
- Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications
- Must be on a stable dose of medication for 1 month prior to Screening
- Are able to successfully complete placebo tablet swallow test
- Have a BMI ≥30 kg/m^2.
Who cannot join
- Have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome)
- Have poorly controlled diabetes mellitus
- Have poorly controlled hypertension
- Have a history of symptomatic hypotension
- Have a history of orthostatic hypotension.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Site 137
Bellevue, Washington, 98007
Site 143
Bentonville, Arkansas, 72712
Site 140
Chicago, Illinois, 60641
Site 153
Culver City, California, 90230
Site 107
Dayton, Ohio, 45417
Site 206
DeSoto, Texas, 75115
Site 239
Garden Grove, California, 92845
Site 138
Glen Burnie, Maryland, 20161
Site 066
Houston, Texas, 77030
Site 151
Las Vegas, Nevada, 89102
Site 134
Lemon Grove, California, 91945
Site 140
Lincolnwood, Illinois, 60712
Site 249
Little Rock, Arkansas, 72211
Site 202
Miami, Florida, 33122
Site 216
New York, New York, 10032
Site 144
North Miami, Florida, 33161
Site 126
Oakland, California, 94607
Site 163
Oceanside, California, 92056
Site 241
Okeechobee, Florida, 34972
Site 181
Raleigh, North Carolina, 27608
Site 181
Raleigh, North Carolina, 27610
Site 229
Rancho Cucamonga, California, 91730
Site 165
Richardson, Texas, 75080
Site 139
Salt Lake City, Utah, 84105
Site 235
Thorndale, Pennsylvania, 19372
Site 235
West Chester, Pennsylvania, 19380
Site 146
Wichita, Kansas, 67214
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with antipsychotic medications.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.
Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks.
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Being tested
- Miricorilant, Placebo
- Keywords
- Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Quetiapine, Olanzapine, Bipolar Disorder
- Medical subject headings
- Obesity, Weight Gain, Mental Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiricorilantDrug
Also called CORT118335
Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
PlaceboDrug
Placebo tablets for once-daily oral dosing
| Study group | Role | What they receive |
|---|---|---|
| Miricorilant 600 mg | Experimental | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks. Receives: Drug: Miricorilant |
| Placebo | Placebo comparator | Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo
Measured: Baseline Day 1 and Week 12
Number of Patients With One or More Treatment-emergent Adverse Events
Measured: Up to Follow-up Visit (Week 16)
Number of Patients With One or More Treatment-emergent Serious Adverse Events
Measured: Up to Follow-up Visit (up to Week 16)
Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation
Measured: Up to Follow-up Visit (up to Week 16)
Secondary outcomes (3)
Percentage of Patients Achieving More Than or Equal to 5% Weight Loss
Measured: Baseline Day 1 to Week 12
Change From Baseline in HOMA-IR at Week 12
HOMA-IR = [fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score >1.9 indicates early insulin resistance and a score >2.9 indicates significant insulin resistance.
Measured: Baseline Day 1 and Week 12
Change From Baseline in Waist-to-hip Ratio at Week 12
Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio <0.95 in men and <0.80 in women is considered healthy.
Measured: Baseline Day 1 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start4 Dec 2019
- Primary completion17 Jun 2022
- Study completion6 Jul 2022
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 Antipsychotic-induced Weight Gain (AIWG)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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kavita Juneja, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818256
- Sponsor's protocol ID
- CORT118335-876
- Acronym
- GRATITUDE
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
- ClinicalTrials.gov ID
- NCT03818256
- Acronym / sponsor ID
- GRATITUDE / CORT118335-876
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Keywords
- Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Quetiapine, Olanzapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 19 Sep 2024
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, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with antipsychotic medications.
Detailed description
This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.
Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miricorilant 600 mg | Experimental | Drug: MiricorilantPatients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients who meet the entry criteria will be randomized to receive placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of schizophrenia or bipolar disorder
- Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications
- Must be on a stable dose of medication for 1 month prior to Screening
- Are able to successfully complete placebo tablet swallow test
- Have a BMI ≥30 kg/m^2.
Key exclusion criteria (5 listed)
- Have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome)
- Have poorly controlled diabetes mellitus
- Have poorly controlled hypertension
- Have a history of symptomatic hypotension
- Have a history of orthostatic hypotension.
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: CORT118335Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing | Drug | Miricorilant 600 mg |
| PlaceboPlacebo tablets for once-daily oral dosing | Drug | Placebo |
Primary outcome
Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo
Time frame: Baseline Day 1 and Week 12
Number of Patients With One or More Treatment-emergent Adverse Events
Time frame: Up to Follow-up Visit (Week 16)
Number of Patients With One or More Treatment-emergent Serious Adverse Events
Time frame: Up to Follow-up Visit (up to Week 16)
Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation
Time frame: Up to Follow-up Visit (up to Week 16)
3 secondary outcomes
Percentage of Patients Achieving More Than or Equal to 5% Weight Loss
Time frame: Baseline Day 1 to Week 12
Change From Baseline in HOMA-IR at Week 12
Time frame: Baseline Day 1 and Week 12
Change From Baseline in Waist-to-hip Ratio at Week 12
Time frame: Baseline Day 1 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Antipsychotic-induced Weight Gain (AIWG)
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Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial
Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain
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.
Kavita Juneja, MD study director
Corcept Therapeutics
27 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 Antipsychotic-induced Weight Gain (AIWG), run by Corcept Therapeutics at 27 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 19 Sep 2024). 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?
Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo (time frame: Baseline Day 1 and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.