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:

Single Ascending Dose (SAD) group — for healthy adults:

• People who are willing to take part, understand what the study involves, and are able to sign a consent form
• Healthy adults aged 18 to 45 years, of any sex
• Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (BMI) between 19.0 and 35.0
• People whose health check results (including vital signs, blood tests, heart tracing, scans, and physical examination) are normal or show only minor findings the study doctor considers unimportant
• People who agree to use effective contraception from signing the consent form until 6 months after the last dose, and who have no plans to become pregnant, father a child, or donate eggs or sperm during that time
• People whose blood sugar marker (HbA1c, a measure of average blood sugar over time) is below 5.7% at the screening visit

Multiple Ascending Dose (MAD) group — for adults with overweight or obesity:

• People who are willing to take part, understand what the study involves, and are able to sign a consent form
• Adults aged 18 to 65 years, of any sex
• People with a BMI of 28.0 or above (obesity range); or people with a BMI between 24.0 and 28.0 (overweight range) who also have at least one of the following: pre-diabetes, high blood pressure, abnormal cholesterol or fats in the blood, fatty liver, joint pain related to weight, breathing difficulties related to weight, or obstructive sleep apnea
• People whose weight has changed by less than 5% over at least 12 weeks of trying to manage their weight through diet and exercise alone, before the screening visit
• People who agree to use effective contraception from signing the consent form until 6 months after the last dose, and who have no plans to become pregnant, father a child, or donate eggs or sperm during that time
• People whose HbA1c blood sugar marker is below 6.5% at the screening visit

Who may not be able to join:

SAD group:

• People who have been diagnosed with type 1, type 2, or any other form of diabetes
• People who have a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma), thyroid C-cell changes, or a related hormonal condition called multiple endocrine neoplasia type 2 (MEN2), or who have a known genetic risk for these conditions
• People who have or are suspected to have pancreas inflammation (pancreatitis), or who have had part or all of their pancreas removed
• People diagnosed with any cancer in the 5 years before screening (except for a type of skin cancer called basal cell carcinoma that has been fully treated and considered cured)
• People who have significant ongoing health conditions, including but not limited to problems with the digestive system, kidneys, liver, nervous system, blood, hormones, lungs, immune system, mental health, or heart
• People who have a condition that affects how their stomach empties or how their gut absorbs nutrients
• People who have had major surgery in the 3 months before screening, or who have surgery planned during the study period
• People who have had an allergic reaction to the study drug or its ingredients, or who have a history of allergies to two or more medications or foods
• People who have used medications (prescription, over-the-counter, herbal, or supplements) in the 3 months before screening that the study doctor considers likely to significantly affect weight or blood sugar
• People who have previously had weight-loss (bariatric) surgery
• People who have a history of recurring skin conditions such as hives, or who have skin problems at the site where the study drug would be injected
• People who have used steroid medications throughout the whole body (not creams, eye drops, nasal sprays, joint injections, or inhalers) for more than 2 weeks in the 3 months before screening, or any such steroid use in the month before screening
• Women with a haemoglobin level below 110 g/L or men with a haemoglobin level below 120 g/L at screening, or people with a known condition that makes the HbA1c test unreliable (confirm with trial site)
• People who have had thoughts of suicide or suicidal behaviour in the 6 months before screening
• People who have used certain weight- or blood sugar-related medications known as GLP-1 receptor agonists (including combination types) in the 6 months before screening
• People who regularly drink more than 14 units of alcohol per week in the 3 months before screening (1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine), or who test positive for alcohol at screening, or who are unable to follow the study's alcohol rules
• People who have a history of drug misuse or illegal drug use in the 2 years before screening, or who test positive for drugs in a urine test before the first dose
• People who have smoked more than 5 cigarettes per day in the 3 months before screening, or who cannot avoid smoking during intensive blood sample collection periods
• People who have a fear of needles or blood, or who have difficulty with blood draws
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People whose liver function blood test results are above 1.5 times the upper limit of normal for certain markers (ALT, AST, or alkaline phosphatase), or whose total bilirubin is above 1.5 times the upper limit of normal
• People whose blood levels of amylase or lipase (enzymes related to pancreas function) are above the normal range at screening
• People whose blood calcitonin level (a marker related to thyroid health) is 20 ng/L or above at screening
• People whose fasting blood sugar is 6.1 mmol/L or above, or below 3.9 mmol/L at screening
• People whose kidney filtration rate (GFR) is below 90 mL/min/1.73m² at screening
• People whose heart electrical tracing (ECG) shows a QT interval that is too long (above 450 ms for men or 470 ms for women, using a specific correction method)
• People who have used certain medications that strongly affect how the liver breaks down drugs in the 4 weeks before the first dose, including medicines such as ciprofloxacin, itraconazole, ketoconazole, ritonavir, rifampin, carbamazepine, phenytoin, or St. John's Wort (among others)
• People who have used any prescription drugs, over-the-counter medicines, vitamins, or herbal medicines in the 2 weeks before the first dose
• People who have eaten grapefruit or drunk grapefruit juice in the 48 hours before the first dose
• People who have eaten chocolate or consumed caffeine-containing or xanthine-containing foods or drinks in the 48 hours before the first dose
• People who have donated 200 mL or more of blood, donated blood components, or lost 200 mL or more of blood for any reason in the 3 months before screening, or who have received a blood transfusion or blood products
• People who have taken part in another clinical trial in the 3 months before screening (people who signed up for a trial but never received any treatment may still be considered)
• People who develop an acute illness or need to start a new medication between signing the consent form and receiving the first dose
• Women who are currently breastfeeding or who have a positive pregnancy test at screening
• People the study doctor considers unsuitable for the trial for any other reason

MAD group:

• People who have been diagnosed with type 1, type 2, or any other form of diabetes
• People whose overweight or obesity is caused by another medical condition or medication, such as Cushing's syndrome
• People who have a personal or family history of medullary thyroid carcinoma, thyroid C-cell changes, or multiple endocrine neoplasia type 2 (MEN2), or who have a known genetic risk for these conditions
• People who have or are suspected to have pancreas inflammation (pancreatitis), or who have had part or all of their pancreas removed
• People diagnosed with any cancer in the 5 years before screening (except for basal cell carcinoma that has been fully treated and considered cured)
• People who have significant ongoing health conditions, including but not limited to problems with the digestive system, kidneys, liver, nervous system, blood, hormones, lungs, immune system, mental health, or heart — not counting health problems directly related to excess weight
• People who have had, in the 6 months before screening or before being enrolled, serious heart or blood vessel problems such as severe heart failure, heart attack, unstable chest pain, uncontrolled abnormal heart rhythms, coronary bypass surgery, certain heart procedures, stroke, mini-stroke, or liver cirrhosis
• People who have a condition that affects how their stomach empties or how their gut absorbs nutrients
• People who have had major surgery in the 3 months before screening, or who have surgery planned during the study period
• People who have had an allergic reaction to the study drug or its ingredients, or to paracetamol (acetaminophen) or its ingredients, or who have a history of allergies to two or more medications or foods
• People who have used medications (prescription, over-the-counter, herbal, or supplements) in the 3 months before screening that the study doctor considers likely to significantly affect body weight
• People who have been taking cholesterol-lowering or blood pressure medications at an unstable dose in the 30 days before screening
• People who have previously had weight-loss (bariatric) surgery
• People who have a history of recurring skin conditions such as hives, or who have skin problems at the site where the study drug would be injected
• People who have used steroid medications throughout the whole body (not creams, eye drops, nasal sprays, joint injections, or inhalers) for more than 2 weeks in the 3 months before screening, or any such steroid use in the month before screening
• Women with a haemoglobin level below 110 g/L or men with a haemoglobin level below 120 g/L at screening, or people with a known condition that makes the HbA1c test unreliable (confirm with trial site)
• People who have had thoughts of suicide or suicidal behaviour in the 6 months before screening
• People who have a history of depression or other mental health conditions in the 6 months before screening
• People who have used GLP-1 receptor agonist medications (including combination types) in the 6 months before screening
• People who regularly drink more than 14 units of alcohol per week in the 3 months before screening, or who test positive for alcohol at screening, or who are unable to follow the study's alcohol rules
• People who have a history of drug misuse or illegal drug use in the 2 years before screening, or who test positive for drugs in a urine test before the first dose
• People who have smoked more than 5 cigarettes per day in the 3 months before screening, or who cannot avoid smoking during intensive blood sample collection periods
• People who have a fear of needles or blood, or who have difficulty with blood draws
• People whose resting seated blood pressure at screening is too high (above 160/100 mmHg) or too low (below 90/55 mmHg)
• People whose resting heart rate at screening is above 100 or below 50 beats per minute
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People whose liver function blood test results are above 2 times the upper limit of normal for ALT or AST, or above 1.5 times the upper limit of normal for alkaline phosphatase or total bilirubin
• People whose blood levels of amylase or lipase are above the normal range at screening
• People whose blood calcitonin level is 20 ng/L or above at screening
• People whose fasting triglyceride (blood fat) level is 5.6 mmol/L or above at screening
• People whose fasting blood sugar is 7.0 mmol/L or above, or below 3.9 mmol/L at screening, or whose blood sugar 2 hours after a sugar drink is 11.1 mmol/L or above
• People whose kidney filtration rate (GFR) is below 90 mL/min/1.73m² at screening
• People whose ECG shows a QT interval that is too long (above 450 ms for men or 470 ms for women), or who have a significant abnormal heart rhythm
• People