Antipsychotic-induced Weight GainPhase 1NCT03877562
The Effect of CORT118335 on Olanzapine-Induced Weight Gain
A Phase 1 study testing Olanzapine and CORT118335 in people with Antipsychotic-induced Weight Gain, run by Corcept Therapeutics at 1 site in United Kingdom.
Trial summary
This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Antipsychotic-induced Weight Gain
- What is being tested?
- Olanzapine and CORT118335
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 25 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 18.0 to 25.0 kg/m^2, inclusive
- Stable body weight as indicated by assessment at screening and pre-dose
- Able to swallow the size and number of tablets required
- Provide written informed consent and agree to adhere to study restrictions and contraception requirements.
Who cannot join
- Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT118335 at any time
- Employee, or immediate family member of a study site or Sponsor employee
- Have a pregnant partner
- History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
- Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
- Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
Show all 16Show fewer
- History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, or gastrointestinal disease, neurological or psychiatric disorder
- History of jaundice or gallstones or had a cholecystectomy
- Family history or known risk for narrow angle glaucoma
- Consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
- Any condition that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism (e.g., asthma, any chronic inflammatory condition, postural hypotension/orthostatic symptoms)
- Presence or history of clinically significant allergy
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Are taking, or have taken, any prescribed or over-the-counter drug within 14 days other than paracetamol or standard dose multivitamins. Longer restrictions apply for some medicines.
- Lactose intolerance.
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
- Conditions
- Antipsychotic-induced Weight Gain
- Being tested
- Olanzapine, CORT118335, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Olanzapine 10 mg oral tablet
CORT118335Drug
CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets
PlaceboDrug
Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine plus CORT118335 | Experimental | Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days. Receives: Drug: Olanzapine; Drug: CORT118335 |
| Olanzapine plus Placebo | Placebo comparator | Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days. Receives: Drug: Olanzapine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Body Weight
Measured: Pre-dose on Day 1 (Baseline) and Day 15
Secondary outcomes (11)
Percentage of Participants with One or More Adverse Events
Measured: Up to Day 28
Percentage of Participants with One or More Serious Adverse Events
Measured: Up to Day 28
Percentage of Participants Discontinued from the Study due to an Adverse Event
Measured: Up to Day 28
Mean Change from Baseline in Glucose
Measured: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Insulin
Measured: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Measured: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Triglycerides
Measured: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Waist-to-Hip Ratio
Measured: Pre-dose on Day 1 (Baseline), Days 8, 15, and 28
Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax)
Measured: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Plasma PK of CORT118335: Maximum Observed Concentration (Cmax)
Measured: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau)
Measured: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Apr 2019
- Primary completion13 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antipsychotic-induced Weight GainStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877562
- Sponsor's protocol ID
- CORT118335-852
- Other IDs
- 2019-000633-39, 2019
- Status last verified
- Apr 2020
- First submitted
- 14 Mar 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03877562
- Acronym / sponsor ID
- CORT118335-852
- Conditions
- Antipsychotic-induced Weight Gain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine plus CORT118335 | Experimental | Drug: Olanzapine, Drug: CORT118335Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days. |
| Olanzapine plus Placebo | Placebo comparator | Drug: Olanzapine, Drug: PlaceboParticipants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index 18.0 to 25.0 kg/m^2, inclusive
- Stable body weight as indicated by assessment at screening and pre-dose
- Able to swallow the size and number of tablets required
- Provide written informed consent and agree to adhere to study restrictions and contraception requirements.
Key exclusion criteria (16 listed)
- Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT118335 at any time
- Employee, or immediate family member of a study site or Sponsor employee
- Have a pregnant partner
- History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
- Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
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 |
|---|---|---|
| OlanzapineOlanzapine 10 mg oral tablet | Drug | Olanzapine plus CORT118335, Olanzapine plus Placebo |
| CORT118335CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets | Drug | Olanzapine plus CORT118335 |
| PlaceboPlacebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available | Drug | Olanzapine plus Placebo |
Primary outcome
Mean Change from Baseline in Body Weight
Time frame: Pre-dose on Day 1 (Baseline) and Day 15
11 secondary outcomes
Percentage of Participants with One or More Adverse Events
Time frame: Up to Day 28
Percentage of Participants with One or More Serious Adverse Events
Time frame: Up to Day 28
Percentage of Participants Discontinued from the Study due to an Adverse Event
Time frame: Up to Day 28
Mean Change from Baseline in Glucose
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Insulin
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Triglycerides
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Waist-to-Hip Ratio
Time frame: Pre-dose on Day 1 (Baseline), Days 8, 15, and 28
Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax)
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Plasma PK of CORT118335: Maximum Observed Concentration (Cmax)
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau)
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- 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.
Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olanzapine and CORT118335 in people with Antipsychotic-induced Weight Gain, run by Corcept Therapeutics at 1 site in United Kingdom.
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 16 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Change from Baseline in Body Weight (time frame: Pre-dose on Day 1 (Baseline) and Day 15). 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 28 Apr 2020.