Antipsychotic-induced Weight Gain (AIWG)Phase 2NCT04524403
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
A Phase 2 study testing Miricorlilant in people with Antipsychotic-induced Weight Gain (AIWG), run by Corcept Therapeutics at 40 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 patients with schizophrenia 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?
- Miricorlilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 40 sitesUnited States
- Study dates
- 9 Sep 2020to 25 Aug 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
- Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications
- Must be on a stable dose of medication for 1 month prior to Screening
- 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
- Have a history of a seizure disorder.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Site #223
Austin, Texas, 78754
Site #137
Bellevue, Washington, 98007
Site #143
Bentonville, Arkansas, 72712
Site # 244
Cedarhurst, New York, 11516
Site # 248
Charlotte, North Carolina, 28211
Site # 240
Chicago, Illinois, 60640
Site #140
Chicago, Illinois, 60641
Site #153
Culver City, California, 90230
Site #107
Dayton, Ohio, 45417
Site #206
DeSoto, Texas, 75115
Site #225
Flowood, Mississippi, 39232
Site #239
Garden Grove, California, 92845
Site # 243
Glendale, California, 91206
Site #066
Houston, Texas, 77030
Site #151
Las Vegas, Nevada, 89102
Site #134
Lemon Grove, California, 91945
Site #217
Lincoln, Nebraska, 68526
Site #140
Lincolnwood, Illinois, 60712
Site # 249
Little Rock, Arkansas, 72211
Site #202
Miami, Florida, 33122
Site #144
Miami Lakes, Florida, 33016
Site #216
New York, New York, 10032
Site # 245
New York, New York, 10036
Site # 230
North Canton, Ohio, 44720
Site #144
North Miami, Florida, 33161
Site #163
Oceanside, California, 92056
Site #241
Okeechobee, Florida, 34972
Site #166
Philadelphia, Pennsylvania, 19125
Site # 247
Pico Rivera, California, 90660
Site #181
Raleigh, North Carolina, 27608
Site # 181
Raleigh, North Carolina, 27610
Site # 229
Rancho Cucamonga, California, 91730
Site #165
Richardson, Texas, 75080
Site # 237
San Diego, California, 92103
Site #224
St Louis, Missouri, 63125
Site # 150
Stanford, California, 94305
Site #231
Staten Island, New York, 10312
Site #231
Staten Island, New York, 10314
Site #235
Thorndale, Pennsylvania, 19372
Site #235
West Chester, Pennsylvania, 19380
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia 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 who are currently taking olanzapine, risperidone, paliperidone, or quetiapine.
Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Being tested
- Miricorlilant, Placebo
- Keywords
- Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Paliperidone, Quetiapine, Olanzapine
- Medical subject headings
- Obesity, Weight Gain, Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiricorlilantDrug
Also called CORT118335
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
MiricorlilantDrug
Also called CORT118335
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
PlaceboDrug
Placebo for once-daily oral dosing
| Study group | Role | What they receive |
|---|---|---|
| Miricorlilant 600 mg | Experimental | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Receives: Drug: Miricorlilant |
| Miricorlilant 900 mg | Experimental | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Receives: Drug: Miricorlilant |
| Placebo | Placebo comparator | Patients who meet the entry criteria will be randomized to receive placebo for 26 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
Measured: Baseline Day 1 and Week 26
Secondary outcomes (3)
Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo
Measured: Baseline Day 1 and Week 26
Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo
Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo
Measured: Baseline Day 1 to Week 26
Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo
Measured: Baseline Day 1 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start9 Sep 2020
- Primary completion29 Jul 2022
- Study completion25 Aug 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
- 150 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
- NCT04524403
- Sponsor's protocol ID
- CORT118335-877
- Status last verified
- May 2024
- First submitted
- 6 Aug 2020
- Last updated
- 13 Jun 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 13 Jun 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 in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
- ClinicalTrials.gov ID
- NCT04524403
- Acronym / sponsor ID
- CORT118335-877
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Keywords
- Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Paliperidone, Quetiapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Posted 13 Jun 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 patients with schizophrenia 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 who are currently taking olanzapine, risperidone, paliperidone, or quetiapine.
Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.
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 |
|---|---|---|
| Miricorlilant 600 mg | Experimental | Drug: MiricorlilantPatients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. |
| Miricorlilant 900 mg | Experimental | Drug: MiricorlilantPatients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients who meet the entry criteria will be randomized to receive placebo for 26 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of schizophrenia
- Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications
- Must be on a stable dose of medication for 1 month prior to Screening
- Have a BMI ≥30 kg/m^2.
Key exclusion criteria (6 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 |
|---|---|---|
| MiricorlilantAlso: CORT118335Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing | Drug | Miricorlilant 600 mg |
| MiricorlilantAlso: CORT118335Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing | Drug | Miricorlilant 900 mg |
| PlaceboPlacebo for once-daily oral dosing | Drug | Placebo |
Primary outcome
Change From Baseline in Body Weight
Time frame: Baseline Day 1 and Week 26
3 secondary outcomes
Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo
Time frame: Baseline Day 1 and Week 26
Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo
Time frame: Baseline Day 1 to Week 26
Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo
Time frame: Baseline Day 1 and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
Kavita Juneja, MD study director
Corcept Therapeutics
40 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 Miricorlilant in people with Antipsychotic-induced Weight Gain (AIWG), run by Corcept Therapeutics at 40 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 4 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: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 13 Jun 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 (time frame: Baseline Day 1 and Week 26). 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 13 Jun 2024.