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:

• A parent, guardian, or legal representative must agree to the child taking part by signing a consent form before any study activities begin, and the child must also give their agreement (by signing or speaking their agreement, depending on their age and local rules).
• Children and teenagers who are male or female.
• Children aged 8 up to (but not including) 18 years old at the time consent is signed.
• Children aged 8 to under 12 whose body weight falls at or above the 95th percentile on a standard BMI chart for their age and sex.
• Teenagers aged 12 to under 18 whose BMI is at or above the 95th percentile, OR at or above the 85th percentile if they also have at least one health condition related to obesity — such as type 2 diabetes, high blood pressure, abnormal cholesterol levels, or sleep apnoea.
• Children whose blood test results for calcium, phosphate, alkaline phosphatase, and parathyroid hormone fall within the normal range for their age and sex, as measured by the study's central laboratory.
• Children who have previously tried but not succeeded in losing enough weight through a structured programme involving diet and exercise guidance for at least 3 months.
• Children who weigh more than 45 kilograms at the screening visit.

For children who have type 2 diabetes, these additional criteria also apply:

• A blood sugar marker called HbA1c must be 10.0% or below, as measured by the study laboratory.
• The child must be managing their diabetes through lifestyle changes alone, or with a medicine called metformin, in line with local medical guidelines.
• If the child is taking metformin, the dose and frequency must have stayed the same for at least 56 days before the screening visit.

Who may not be able to join:

• Children who have taken any prescription medication for obesity or weight management in the 90 days before the screening visit.
• Children who have previously had surgery or a medical device used for weight loss, or who have this planned during the study period — with some exceptions for certain procedures completed more than 1 year before screening (confirm with trial site).
• Children with a thyroid condition that is not well controlled.
• Children whose obesity is caused by a hormonal, brain-related, or genetic syndrome.
• Children whose body weight has changed by more than 5% in the 90 days before screening, as reported by the child or their parent or guardian.
• Children with type 1 diabetes or a rare inherited form of diabetes called monogenic diabetes.

For children who do not have type 2 diabetes, these additional exclusion criteria also apply:

• An HbA1c blood sugar result of 6.5% or above at screening, as measured by the study laboratory.
• Use of any medication prescribed for diabetes or pre-diabetes in the 90 days before the screening visit.

For children who do have type 2 diabetes, these additional exclusion criteria also apply:

• A condition where the child cannot tell when their blood sugar is dropping dangerously low (known as hypoglycaemic unawareness), as assessed by the study doctor using a specific questionnaire.
• Repeated serious episodes of very low blood sugar in the year before the screening visit, as judged by the study doctor.
• Certain antibodies in the blood (IA-2 or anti-GAD antibodies) that suggest a different type of diabetes may be present.
• Use of any diabetes medication other than metformin (as described in the inclusion criteria) in the 90 days before the screening visit.
• Eye complications related to diabetes (retinopathy or maculopathy) that are not well controlled and may be unstable, confirmed by an eye examination conducted within 90 days before screening or before the child is enrolled (confirm with trial site).

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