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:

• People with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher if they also have at least one health condition related to their weight (such as high blood pressure or high cholesterol)
• People who have tried at least once in the past to lose weight through diet or lifestyle changes without lasting success
• People who have an established regular doctor or primary care provider

Who may not be able to join:

• People who have been diagnosed with diabetes, are taking diabetes medications, or whose blood sugar test results are above the diabetic threshold
• People whose liver enzyme levels (ALT, AST, or alkaline phosphatase) are three or more times higher than the normal range
• People whose pancreatic enzyme levels (lipase and/or amylase) are two or more times higher than the normal range
• People with a bilirubin blood level above 1.6 mg/dL (a marker of liver or bile function — confirm with trial site)
• People with moderate-to-severe chronic kidney disease, specifically a kidney filtration rate below 45 mL/min
• People with certain abnormal blood count results, including low white blood cells, low neutrophils, low haemoglobin, or low platelets
• People with significant blood clotting problems, based on a specific clotting test result (confirm with trial site)
• People with a family history of very high triglycerides (a type of blood fat), or a fasting triglyceride level above 500 mg/dL
• People with an uncontrolled thyroid condition, meaning both thyroid stimulating hormone and free T4 levels are abnormal at the same time
• People with a current active chronic infection such as HIV, hepatitis B, or hepatitis C, or who have been treated for hepatitis C in the past 6 months
• People with a known history of serious liver disease (such as cirrhosis), gallbladder or bile duct disease, pancreatitis, or conditions that could harm the liver
• People with a significant condition affecting how their stomach empties, or who regularly take medications that affect gut movement
• People with a history of calcium oxalate kidney stones
• People with a history of serious heart or circulation problems, including irregular heart rhythms, unstable chest pain, heart attack, stroke, coronary bypass surgery, heart stents, heart failure, heart valve problems, pulmonary hypertension, chronically low blood pressure (below 100/50), or chronically uncontrolled high blood pressure (above 160/100)
• People with a resting heart rate above 100 beats per minute after sitting quietly for 5 minutes
• People who have had any cancer (other than certain minor skin cancers) within the past 5 years, whether treated or not
• People with a current significant psychiatric diagnosis such as dementia, Alzheimer's disease, schizophrenia, or bipolar disorder (note: people with depression that is well managed on stable treatment for at least 3 months may still be eligible — confirm with trial site)
• People with a prior history of a suicide attempt
• People who score 15 or higher on a standard depression questionnaire (PHQ-9) at the screening visit
• People with a personal or family history of a hereditary condition called multiple endocrine neoplasia type 2A or 2B, or medullary thyroid cancer
• People who currently have an active problem with alcohol, drug, or tobacco use, or who drink more than 14 standard drinks per week (for men) or 7 standard drinks per week (for women)
• People who use cannabis or THC products more than once a week and are not willing to stop for the full length of the study
• People whose weight is caused by another hormonal condition (such as Cushing's syndrome), or by a diagnosed genetic syndrome linked to obesity (such as Prader-Willi syndrome)
• People who have previously had weight loss surgery, or who are planning to have weight loss surgery during the trial period
• People who have used any prescription, supplement, or over-the-counter weight loss product within the past 6 months
• People who have started a new diet or exercise programme for weight loss within the past 3 months
• People whose weight has changed by more than 5 kg in the past 3 months
• People who weigh more than 150 kg, due to limits of the imaging equipment used in the study
• People who have been taking medications known to cause weight gain in the past 3 months (such as certain anti-seizure, hormonal, or psychiatric medications, or oral steroids — excluding antidepressants)
• People who have used muscle-building agents in the past 3 months, such as growth hormone, testosterone, or over-the-counter anabolic supplements
• People who have taken blood sugar-lowering medications within the past 90 days
• People with a known allergy or severe reaction to monoclonal antibody medications, or to drugs in the same class as the study drugs
• People with a history of fragility fractures (bones that break from minor stress), or people over 50 with a bone density T-score of -2.5 or lower
• People who have used intravenous bone-strengthening medications (IV bisphosphonates) within the past 2 years, or other osteoporosis medications within the past 12 months
• People who are unable or unwilling to follow a lifestyle and dietary programme for weight loss, including those who cannot do regular walking for exercise, or who cannot follow a high-protein diet with a 500-calorie daily reduction
• Women who are pregnant or breastfeeding
• Women who are able to become pregnant, unless they are using an intrauterine device (IUD) from at least 3 months before the trial starts through to at least 4 months after the last dose, plus an additional barrier method of contraception from screening through to at least 4 months after the last dose (specific groups of women, such as those who are post-menopausal, have had a hysterectomy, or have other confirmed causes of infertility, may be eligible under different conditions — confirm with trial site)
• Men with a morning testosterone level below 200 ng/dL
• People who are currently enrolled in another medical research study that may conflict with this one
• People who plan to move away from the trial area within 16 months, or who expect to be away from the area for more than 4 consecutive weeks
• People for whom a standard MRI scan is not possible (such as those with certain metal implants — confirm with trial site)
• People who have donated or lost 400 mL or more of blood in the past 2 months, or donated plasma (more than 250 mL) in the past 2 weeks
• People who have major surgery planned or scheduled during the trial period
• People who, in the opinion of the trial investigators, have any other condition or circumstance that could affect their safety or ability to follow the trial requirements

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