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:

Parts A and B (Healthy volunteer portion):

• Men and women aged 18–55 who are generally in good health at the time of screening
• A body mass index (BMI) of 30 or higher (a measure of body weight relative to height)
• Normal or medically unimportant results on health checks at screening
• Willingness and ability to use a highly effective form of contraception throughout the study, as required by the study guidelines
• Ability to understand English, communicate with the study team, and sign a consent form agreeing to take part

Part C (Hypothalamic obesity portion):

• Men and women aged 12–65 who have been diagnosed with hypothalamic obesity (weight gain caused by damage to a part of the brain called the hypothalamus)
• People who have a documented diagnosis of a brain tumour (such as craniopharyngioma) or other brain condition affecting the hypothalamus, and who have had surgery, chemotherapy, or radiation treatment involving the hypothalamus at least 6 months before screening — OR people who have a documented hypothalamus injury at least 6 months before screening that did not require surgery or radiation
• Weight gain linked to the hypothalamic injury, and a BMI of 30 or higher for those aged 18 and over, or a BMI at or above the 95th percentile for their age and sex for those aged 12 to under 18
• Willingness and ability to use a highly effective form of contraception throughout the study
• Ability to communicate with the study team and sign a consent form; for those under 18, a parent or guardian must also provide consent, and the young person must provide their own agreement (assent)

Part D (Prader-Willi syndrome portion):

• Men and women aged 12–65 with a confirmed diagnosis of Prader-Willi syndrome (a genetic condition affecting appetite and weight)
• A BMI of 30 or higher for those aged 18 and over, or a BMI at or above the 95th percentile for their age and sex for those aged under 18, based on US CDC growth standards
• Willingness and ability to meet the contraception requirements of the study

Who may not be able to join:

Parts A and B:

• People with any significant abnormal results on health checks or physical examination at screening
• People with a current or past significant medical condition affecting the kidneys, liver, lungs, digestive system, heart, urinary system, hormones, immune system, metabolism, nervous system, or blood
• People whose obesity is caused by a genetic condition, a syndrome, or a hormonal disorder
• People with a history of kidney transplant or severe kidney disease (end-stage renal disease)
• People with a diagnosis of a severe psychiatric (mental health) disorder
• People with a serious ongoing condition affecting the lungs, heart, metabolism, or cancer that could interfere with the trial
• People who smoke cigarettes, or who are heavily dependent on caffeine, alcohol, or other substances, or who are unable or unwilling to avoid caffeine, alcohol, and related substances for 24 hours before and after study visits
• People who have had surgery within the 60 days before screening
• People who have taken part in another clinical trial involving an experimental drug or device within 3 months or 5 half-lives (whichever is longer) before the first trial dose
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial

Part C:

• People who have a diagnosis of Prader-Willi syndrome or a condition called ROHHADNET (a rare syndrome involving rapid weight gain, breathing difficulties, and nervous system problems)
• People aged 18 and over who have lost more than 2% of their body weight in the previous 3 months, or people aged 12 to under 18 who have had more than a 2% reduction in BMI — or anyone currently using anti-obesity medications
• People who have had weight-loss (bariatric) surgery or a related procedure within the last 2 years
• People with a severe psychiatric disorder, or any history of suicidal thoughts, attempts, or behaviour
• People with a serious ongoing condition affecting the lungs, heart, metabolism, or cancer that could interfere with the trial
• People with a history of kidney transplant or severe kidney disease
• People who have taken part in another clinical trial involving an experimental drug or device within 3 months or 5 half-lives (whichever is longer) before the first trial dose, or who have previously taken part in a trial involving a drug called setmelanotide
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People whose obesity before the hypothalamic injury was caused by another genetic or syndrome-related condition (such as Bardet-Biedl syndrome or certain gene mutations affecting appetite regulation)

Part D:

• People aged 18 and over who have lost more than 2% of their body weight in the previous 3 months, or people aged under 18 who have had more than a 2% reduction in BMI — or anyone currently using treatments for obesity or excessive appetite
• People who have had weight-loss (bariatric) surgery or a related procedure within the last 6 months
• People with a severe psychiatric disorder, or any history of suicidal thoughts, attempts, or behaviour
• People with a serious ongoing condition affecting the lungs, heart, metabolism, or cancer that could interfere with the trial
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial

Important: Other eligibility criteria not listed here may also apply. Always verify eligibility with the trial site directly before applying.