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 aged 18 to 60 years old (male or female) who are able to understand and agree to follow the study requirements
• People with a body mass index (BMI) between 30 and 50 (a measure of body weight relative to height)
• People whose body weight has been stable (less than 5% change) for the past 3 months
• People whose diet and eating habits have stayed roughly the same for the past 3 months
• People with a current diagnosis of prediabetes, provided their blood sugar control measurements fall within specific ranges and they have no history of a serious diabetic emergency called ketoacidosis or hyperosmolar coma (confirm specific values with trial site)
• Women who are not pregnant or breastfeeding, confirmed by a urine pregnancy test at the start of the study
• Women who could become pregnant must agree to use two forms of contraception — one hormonal method (such as the pill, implant, patch, or injection) or an intrauterine device (IUD), combined with a barrier method (such as a condom) — from the screening visit through to at least 30 days after the last dose of the study drug

Who may not be able to join:

• People with poorly controlled serious mental health conditions such as bipolar disorder or major depressive disorder, a psychotic episode in the past 6 months, any history of suicide attempts or suicidal thoughts, or other psychiatric conditions the trial doctor believes would affect participation
• People with a lifetime diagnosis of schizophrenia or schizoaffective disorder, or a diagnosis of bipolar 1 disorder within the past 2 years
• People with a history of bleeding disorders, deep vein thrombosis (blood clots in the veins), or other clotting-related conditions
• People with current liver, kidney, lung, heart, cancer-related, or digestive system disease, including specific heart conditions (such as heart failure, coronary artery disease, heart attack, significant heart rhythm problems, or certain electrical heart abnormalities)
• People whose heart electrical activity reading (ECG) shows a particular measurement called QTcF above a certain threshold (confirm specific values with trial site)
• People with liver disease or abnormal liver blood test results above certain levels, or a history of liver conditions such as cirrhosis or alcoholic hepatitis (people with non-alcoholic fatty liver disease may still be considered if liver tests are within acceptable range — confirm with trial site)
• People with significantly impaired kidney function as measured by a standard medical calculation
• People with Type 1 or Type 2 diabetes, or those who have used insulin for more than one week within the 3 months before screening
• People whose obesity is caused by another medical condition, such as Prader-Willi syndrome or Cushing's syndrome
• People with an active autoimmune disease who are currently using or are likely to need steroid medication (taken throughout the body, not just topically) in the next 6 months
• People who have previously had weight-loss surgery or a medical device inserted for obesity treatment (such as a gastric band or gastric balloon); liposuction performed more than 1 year before screening may be acceptable — confirm with trial site
• People who have had stomach or intestinal surgery that could affect how a drug is absorbed or removed from the body (some minor surgeries performed more than 6 months ago may be acceptable — confirm with trial site)
• People with uncontrolled hormonal or gland-related conditions such as Cushing's syndrome, Addison's disease, Hashimoto's disease, underactive thyroid, or low sex hormone levels
• People with significantly abnormal blood test results at screening, including low haemoglobin, low white blood cell counts, low platelet counts, or abnormal liver markers (specific threshold values should be confirmed with the trial site)
• People with other abnormal screening blood tests or heart tracing (ECG) results that the trial doctor considers clinically significant
• People who weigh more than 350 pounds (approximately 158.8 kilograms), due to the weight limit of the body scanning equipment used in the study
• People who are currently using, or have used within the past 30 days, certain antipsychotic medications including olanzapine, clozapine, or quetiapine
• People taking certain ongoing medications — including some hormone therapies, diabetes medications (other than metformin), some antidepressants, some antipsychotics, ADHD medications, or others — whose dose has not been stable for at least 3 months before entering the study (confirm the full list with the trial site)
• People who have used any prescription or over-the-counter weight-loss medications in the 3 months before screening (including medications such as Saxenda, Wegovy, Zepbound, Xenical, Qsymia, or similar products)
• People who have used steroid medication taken throughout the body (not topical, inhaled, or localised) for more than 2 weeks within the month before screening
• People with unstable vital signs, including blood pressure above 160/100 mmHg or a resting heart rate above 100 beats per minute
• People with a recent or recurring history of fainting or unexplained palpitations within the past year
• People who are currently using or expect to use narcotic or opioid medications for more than 2 days during the study
• People with a significant history of drug or solvent misuse in the past year, or alcohol misuse in the past year, or who currently drink more than 21 standard drinks per week
• People who have taken part in another clinical trial involving an investigational drug or device within the past 3 months
• People who test positive for HIV, hepatitis B, or hepatitis C before starting the study drug
• People with a known serious allergic reaction or sensitivity to any drug that the trial doctor considers relevant to study participation
• People who have donated more than 500 mL of blood or experienced significant blood loss within the past 3 months
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who are planning or likely to need surgery during the course of the study
• People who the trial doctor considers unsuitable for any reason, such as a significant illness in the 8 weeks before screening or an inability to attend scheduled study visits

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