Phase 2 Obesity Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are generally healthy males or females between the ages of 13 and 50 (inclusive)
• People who have a confirmed diagnosis of Prader-Willi Syndrome (PWS) documented in their medical records through genetic testing, and who are in a specific stage of PWS-related eating behaviour (Nutritional Phase 3)
• People whose PWS-related behavioural symptoms have been rated at a certain level of severity on a standard assessment scale at both the screening and baseline appointments (confirm with trial site)
• People whose scores on a specific behavioural questionnaire meet the required threshold at screening (confirm with trial site)
• People who are not currently taking certain medications — including antidepressants (SSRIs, SNRIs, tricyclics, bupropion), stimulants, antipsychotics, or MAO inhibitors — and have not taken them in the 30 days before screening, and who are willing to avoid starting them during the study; people previously on fluoxetine must have stopped it more than 6 months before screening
• People who have a caregiver or parent willing to bring them to study visits, stay with them during visits when permitted, and respond to questions from the study team
• People whose caregiver or parent agrees to give informed consent, follow all study procedures (including telehealth visits), and provide consistent care throughout the study
• People whose caregiver agrees to complete all assessments required by the study
• People who are not able to provide full consent themselves but are able to indicate their agreement to participate (assent)
• Female participants who are not pregnant or breastfeeding; pregnancy will be checked by a urine test at screening and at the baseline visit
• Female participants of childbearing potential who agree to use an accepted form of contraception from screening until at least 30 days after the last dose of study medication — acceptable methods include hormonal contraceptives (pill, injection, implant, patch), an intrauterine device (IUD), or a double barrier method (such as a condom and spermicide); the trial doctor may also consider abstinence if it is realistic for the participant
• Female participants who are not able to become pregnant — either due to surgical procedures (such as hysterectomy, removal of both ovaries, or tubal ligation) or because they have been through menopause (at least one year without a period, confirmed by a hormone blood test) — and who therefore do not need to use contraception
• Male participants who, unless surgically sterile, agree to use a double barrier method (such as a condom and spermicide)
• People whose blood pressure and heart rate fall within the acceptable ranges specified for their age group — for adults, specific systolic, diastolic, and heart rate values apply; for adolescents, blood pressure must fall between the 5th and 90th percentile for their age and sex (confirm with trial site)
• People whose ongoing medications (including blood pressure or diabetes medications) have been stable for at least 3 months before screening with no planned changes during the study; vitamins and supplements are not included in this requirement
• People who are willing and able to follow all study procedures, attend visits, and meet all requirements for the full duration of the study

Who may not be able to join:

• People who have taken part in another clinical trial involving an investigational drug or device within the 3 months before screening, or who are currently in another such trial
• People whose PWS is caused by a specific genetic subtype called maternal uniparental disomy (UPD)
• People who are currently using a medication called DCCR, or who have used it within 4 weeks before screening
• People who have used weight loss treatments — including prescription medications, herbal products, or supplements — within the 3 months before screening; this includes Ozempic (even if used for diabetes), due to its effect on weight
• People who have had bariatric (weight loss) surgery or any major surgery within 6 months before screening, or who have such surgery planned during the study
• People who have had a cancer diagnosis in the 2 years before screening (with some exceptions for certain treated skin or cervical conditions — confirm with trial site)
• People with active liver, lung, heart, or gastrointestinal disease that could interfere with study participation; people with certain abnormal liver test results are also excluded; stable conditions such as well-controlled asthma or high blood pressure are generally not excluded (confirm with trial site)
• People with impaired liver function, regardless of severity
• People with an unexplained combination of symptoms such as dizziness, fainting, extreme tiredness, a racing heart, headaches, or difficulty tolerating exercise
• People currently taking prohibited medications, including SSRIs, SNRIs, bupropion, tricyclic antidepressants, stimulants, antipsychotics, MAO inhibitors, fluoxetine, mood stabilisers, or GLP-1 agonist medications
• People with a condition called postural orthostatic tachycardia syndrome (POTS), where the heart rate rises too quickly upon standing — the specific threshold differs by age group (confirm with trial site)
• People with a clinically significant abnormal result on a heart tracing test (ECG) at screening, including a specific electrical interval measurement that is too long (confirm with trial site)
• People with a clinically significant heart rhythm problem, such as atrial fibrillation or certain types of heart block
• People with heart failure classified at a moderate or severe level on a standard medical scale
• People who have had a heart attack, stroke, or mini-stroke (TIA) within the last 5 years
• People whose kidney function, as measured by a specific blood test, falls below the required level for their age group (confirm with trial site)
• People with poorly controlled type 2 diabetes, as indicated by a blood sugar (HbA1c) level of 9% or higher at screening
• People with insulin-dependent type 1 diabetes
• People who test positive for hepatitis B, hepatitis C (with detectable virus in the blood), or HIV
• People with uncontrolled thyroid disease
• People with a known allergy or sensitivity to any ingredient in the study medication
• People with a history of or current psychotic symptoms, or other severe psychiatric conditions such as schizophrenia, major depressive disorder, or bipolar disorder, that the investigator believes would significantly interfere with study participation
• People with any history of suicidal behaviour
• People with a known history of alcohol or substance misuse
• People taking certain medications that affect how the liver processes drugs, including some inhibitors or inducers of specific liver enzymes, or who regularly consume grapefruit juice (confirm with trial site)
• People with any other medical, physical, or personal issue that, in the trial doctor's judgement, would prevent them from completing the trial as required
• People who are unable to swallow oral capsules whole with water

Important: Always verify eligibility with the trial site directly before applying.