Phase 1 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 18 and 65 years old (male or female) who can give their consent to participate
• People with a Body Mass Index (BMI) between 27.0 and 39.9, where the extra weight is due to body fat (as confirmed by the study doctor)
• People whose weight has been stable, meaning they have not gained or lost more than 5 kg (11 lbs) in the 90 days before the screening visit
• Women who cannot get pregnant, either because they have had a hysterectomy, both fallopian tubes removed, or both ovaries removed, or because they have gone through menopause (no periods for at least 1 year); women under 55 who say they are post-menopausal must have a specific hormone level confirmed by a blood test
• Men whose partners could become pregnant must agree to use a condom or avoid sexual intercourse for the whole study; this does not apply to men who had a vasectomy more than 6 months before joining

For Part B of the trial only (people with Type 2 Diabetes):

• People who have been diagnosed with Type 2 Diabetes for at least 180 days before the screening visit
• People managing their blood sugar through diet and exercise alone, or with a stable dose of metformin and/or a type of medication called SGLT-2 inhibitors, with no dose changes in the 3 months before screening
• People whose HbA1c (a measure of average blood sugar over several months) is between 7.0% and 9.0% at the screening visit

Who may not be able to join:

• People with significant medical conditions affecting the lungs, metabolism, kidneys, liver, digestive system, or hormone system (mild cholesterol or triglyceride problems may be acceptable — confirm with trial site)
• People who have a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related condition called multiple endocrine neoplasia type 2
• People who currently have or have previously had inflammation of the pancreas (pancreatitis)
• People whose excess weight is caused by a hormone disorder (such as Cushing's syndrome) or a genetic condition linked to obesity
• People who have a history of major depression or other serious mental health conditions such as schizophrenia, bipolar disorder, or severe anxiety
• People who have ever attempted suicide or shown suicidal behaviour, as identified by a standard screening questionnaire used at the screening visit
• People with high blood pressure at screening (top number 140 or higher, or bottom number 90 or higher)
• People who have or have had heart or blood vessel problems, including heart attacks, heart failure, stroke, angina, irregular heartbeat, or blood clots

For Part A of the trial only (people without diabetes):

• People who have Type 1 or Type 2 diabetes, or whose blood sugar levels at screening are above certain thresholds (women who had diabetes only during pregnancy may still be eligible — confirm with trial site)

For Part B of the trial only (people with Type 2 Diabetes):

• People whose fasting blood sugar level is very high (above 270 mg/dL) at screening
• People with advanced diabetes-related eye problems, confirmed by an eye examination within the past 1.5 years
• People with severe nerve damage related to diabetes, as judged by the study doctor
• People with advanced kidney damage (defined as a specific level of protein in the urine — confirm with trial site)
• People who have had severe low blood sugar episodes or who do not notice when their blood sugar is dropping dangerously low

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