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:

• Adults between 25 and 60 years of age
• People with a body mass index (BMI) between 30.0 and 39.9, which falls into the obesity grade I–II range
• People who have either mildly underactive thyroid function (with a specific hormone level called TSH between 5 and 10, but other thyroid levels normal), or a thyroid that is considered normal but with TSH in the upper range of normal and no known thyroid condition
• People who are able and willing to sign a consent form agreeing to take part
• Women who could become pregnant may be eligible if they are not currently pregnant or breastfeeding, and are using a highly effective form of contraception (such as hormonal methods, an IUD, sterilisation, or a combination of two barrier methods with spermicide)

Who may not be able to join:

• People with diabetes, based on specific blood sugar test results (confirm with trial site for exact values)
• People who have ever had a thyroid condition such as an overactive or fully underactive thyroid, or who have previously been treated with a thyroid hormone medication called levothyroxine
• People who have used levothyroxine, blood sugar-lowering medications, antibiotics, or regular probiotic or prebiotic supplements in the past 3 months or are currently using them
• People who have had cancer in the past 5 years, except for a common and easily treated skin cancer called basal-cell carcinoma
• People with chronic liver disease with certain elevated liver or bilirubin test results (confirm with trial site for exact values)
• People with established heart or blood vessel disease, such as a history of stroke, heart disease, or poor circulation in the legs
• People with a history of an irregular heartbeat, including atrial fibrillation
• People with high blood pressure above 160/100 mmHg that is not controlled despite treatment, as measured by a blood pressure monitoring test at the screening visit
• People with any form of heart failure, a resting heart rate above 85 beats per minute, or reduced kidney function below a certain level (confirm with trial site)
• People known to have HIV, hepatitis B, or hepatitis C infection
• People with an active inflammatory condition or inflammatory bowel disease
• People with a serious underlying health condition that, in the opinion of the trial doctor, could affect their ability to participate
• People with drug or alcohol misuse issues, a life expectancy of less than 12 months, or those who are unable to follow the recommended diet or attend study visits
• People who are pregnant, have a positive pregnancy test, are planning to become pregnant, or are breastfeeding
• People with a known allergy or sensitivity to any ingredient in the study treatment
• People who are unable or unwilling to provide informed consent

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