Phase 3 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 have a confirmed medical record showing they carry non-working (loss of function) copies of the LEP gene inherited from both parents, documented before the screening visit
• People who have been assessed as having class 2 or higher obesity (a specific level of obesity as defined by the trial) at both the screening and baseline appointments

Who may not be able to join:

• People who are unwilling or unable to provide, or have their treating doctor provide, recorded weight history from at least 6 months before the screening visit
• People who have had weight-loss (bariatric) surgery within approximately the past 12 months before screening
• People who have lost 5% or more of their body weight in approximately the 3 months before screening
• People who have a genetic cause of obesity other than, or in addition to, the non-working LEP gene variants described above
• People who have a history of schizophrenia, bipolar disorder, or another mental illness that the trial investigator believes could pose a safety risk during participation
• People who have had certain levels of suicidal thoughts (rated 4 or 5 on a specific clinical scale) during the screening or baseline period, or who have any history of a suicide attempt or suicidal behaviour at any point in their life
• People who have taken weight-loss medications, or medications known to cause weight loss as a side effect, within approximately the past 3 months before screening
• People who are currently being treated with a medicine called metreleptin, or who have previously been treated with metreleptin as defined by the trial protocol

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