Phase 4 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 aged 18 to 70 years (male or female)
• People who had a sleeve gastrectomy or Roux-en-Y gastric bypass surgery at least 18 months ago
• People who have regained at least 5% of their lowest weight reached after surgery
• People with a body mass index (BMI) of 30 or above, or a BMI of 27 or above if they also have health conditions related to their weight
• Women who could become pregnant must be using suitable contraception for the duration of the study and must have a negative pregnancy test at the start
• People who are able to read and sign a consent form agreeing to take part

Who may not be able to join:

• People with type 1 diabetes
• People with type 2 diabetes who require insulin
• People with a fasting blood sugar level of 240 mg/dL or higher
• People with high blood pressure that is not well controlled (systolic of 150 mmHg or higher, and/or diastolic of 100 mmHg or higher)
• People with a significant or unstable heart condition, including coronary artery disease, irregular heartbeat, severe heart failure, or a history of stroke
• People currently taking, or who have taken in the past two weeks, a type of medication called monoamine oxidase inhibitors (MAOIs)
• People with an overactive thyroid or other serious thyroid conditions
• People with a specific type of glaucoma called angle-closure glaucoma
• People experiencing states of severe agitation
• People with a history of drug abuse in the past year
• People who have a known allergy or unusual reaction to a group of substances called sympathomimetic amines (confirm with trial site)
• People with severe liver disease (certain milder liver conditions may still be acceptable — confirm with trial site)
• People with end-stage kidney disease
• People with a history of kidney stones
• People with blood triglyceride (fat) levels of 500 mg/dL or higher
• People with an active cancer diagnosis in the past two years, unless it was a specific type of skin cancer or early-stage cervical cancer that has been adequately treated
• People with a history of psychosis or bipolar disorder
• People who have had thoughts of suicide, or who have unstable or untreated severe depression, within the past year
• People taking antidepressant medication unless the dose has been stable for at least three months
• People who score 11 or higher on a standardised anxiety or depression questionnaire used by the trial (confirm with trial site)
• People who score 27 or higher on a standardised binge eating questionnaire used by the trial (confirm with trial site)
• People with an alcohol use disorder within the past year
• People with epilepsy
• People currently taking phentermine, topiramate, or any product containing these medications
• People currently taking stimulant medications, such as those used for ADHD
• People currently using any prescription or over-the-counter weight loss medications or supplements
• People taking any medication or product that, in the investigator's opinion, could significantly affect body weight
• People who are planning to have further weight loss surgery within the next 13 months
• People who have previously had revision bariatric surgery (though revision after adjustable gastric banding may be acceptable — confirm with trial site)
• People currently taking part in another weight loss programme, or planning to join one within the next 13 months
• People who stopped smoking within the past three months, or who plan to quit smoking in the next 13 months
• People who are pregnant, breastfeeding, or planning to become pregnant in the next 13 months
• People with any other existing condition that the principal investigator believes could interfere with the study or pose an unacceptable risk

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