Phase 1 Obesity Trial, Recruiting

Written by an AI model from the 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 60 years old (at least 80% of participants must be Caucasian, as of 2 September 2025)
• For the single-dose part of the trial (Part A): people with a body mass index (BMI) between 19.0 and 40.0, and a body weight between 65 kg and 130 kg
• For the multiple-dose part of the trial (Part B): people with a BMI between 27.0 and 45.0, and a body weight between 65 kg and 130 kg
• People whose body weight has been stable (changed less than 5% by their own report) for the 3 months before the screening visit
• People whose resting heart rate (measured lying down) is between 45 and 90 beats per minute on a heart tracing (ECG) test at screening
• Women who could become pregnant, and men who have not had a vasectomy more than 180 days ago (with confirmed absence of viable sperm), who agree to use contraception from screening until 4 months after the last dose — OR women who cannot become pregnant because they have gone through menopause, had their uterus removed, or had both ovaries removed
• People who agree not to donate sperm or eggs from the screening period until 4 months after the last dose
• People willing to keep their usual diet and exercise habits, avoid strenuous activity in the 72 hours before each blood test, and avoid alcohol and smoking during the study
• People who are able to understand and willing to sign a consent form and follow all study rules

Who may not be able to join:

• People with a significant history or current signs of heart, metabolic, allergy, hormonal, kidney, liver, digestive, blood, lung, breathing, skin, neurological, gynaecological, or mental health conditions, as determined by the lead doctor
• People whose blood pressure at screening (measured lying down) falls outside the range of 90–159 mmHg (top number) or 50–95 mmHg (bottom number)
• People with a history of a type of tumour that causes low blood sugar (insulinoma), a blood sugar episode below 2.8 mmol/L in the past year, or three or more low blood sugar episodes in the past 3 months
• People who have had a fever-causing illness in the 7 days before the first dose, or who show signs of an active infection
• People with certain abnormal heart tracing (ECG) results, including specific measurements outside accepted ranges, or a personal or family history of a heart rhythm condition called long QT syndrome or related risk factors
• People with a known personal or family history of a type of thyroid tumour or cancer, a condition called multiple endocrine neoplasia type 2, thyroid problems, or abnormal thyroid hormone levels
• People with a history of diabetes, or blood sugar or related test results at screening that suggest diabetes, or who have used blood-sugar-lowering medications within 3 months before screening
• People with a history of acute or chronic pancreatitis, gallbladder disease, pancreatic injury, or other conditions that significantly raise the risk of pancreatitis
• People with certain abnormal blood test results at screening, including elevated pancreatic enzymes, liver enzymes, or bilirubin above 1.5 times the normal upper limit; triglycerides at or above 5.65 mmol/L; or kidney function below a set threshold
• People with untreated or uncontrolled thyroid conditions based on specific thyroid hormone test results
• People with a history of significant stomach-emptying problems or long-term digestive conditions such as active ulcer, gastritis, reflux disease, irritable bowel, or severe inflammatory bowel disease
• People with significant current digestive symptoms (such as nausea, vomiting, heartburn, or diarrhoea) or conditions affecting nutrient absorption (such as coeliac disease, lactose intolerance, or chronic pancreatitis)
• People with any history of stomach or bowel surgery, except appendix removal
• People who test positive for hepatitis B, hepatitis C, or HIV
• People with a history of serious mental health conditions such as major depression, bipolar disorder, schizophrenia, or any history of suicidal thoughts or attempts
• People with a history of alcohol or drug/chemical misuse within the past year
• People who drink more than 21 units of alcohol per week on average (for men) or more than 14 units per week on average (for women)
• People who test positive for alcohol or drugs during the screening period
• People who smoke more than 10 cigarettes per day, 2 cigars per day, or an equivalent amount of any nicotine product, on average, in the 6 weeks before screening
• People who are unwilling to avoid strenuous exercise in the 72 hours before each blood test
• Women who are pregnant, breastfeeding, or have a positive pregnancy test at screening
• People who are unable to tolerate blood draws from a vein, or who have a history of fainting during or at the sight of blood draws (unless the lead doctor considers it acceptable)
• People who have regularly used medications that affect gut movement (such as mosapride or cisapride) or who have had gut surgery within 12 weeks before screening, where the lead doctor considers this a problem
• People with a history of serious allergic reactions (including anaphylaxis or cytokine release syndrome), or allergies to multiple medications
• People with a known or suspected allergy or sensitivity to the study drug or its ingredients
• People who have used or plan to use any prescription medications (other than hormone replacement therapy or contraceptives) within 14 days before the first dose, unless approved by the lead doctor and the study sponsor
• People who have used or plan to use slow-release medications still considered active within 14 days before the first dose, unless approved by the lead doctor
• People who have used non-prescription products — including vitamins, minerals, or herbal supplements — within 7 days before the first dose or during the study, unless approved by the lead doctor and sponsor (paracetamol/acetaminophen up to 2 g per day for up to 3 days, and topical medications used more than 48 hours before dosing, are exceptions)
• People who have had a serious infection, severe injury, or major surgery within 4 weeks before screening
• People who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the study
• People who have donated blood or lost more than 450 mL of blood, received blood products within 12 weeks before screening, received plasma within 2 weeks before screening, or received platelets within 6 weeks before screening
• People who have taken part in another clinical trial with an experimental drug or device within 30 days or 5 half-lives before screening, or received a biological medicine within 12 weeks before screening
• People with poor vein access for blood draws
• Staff members working directly on this trial, or their immediate family members (spouse, parent, child, or sibling)
• People with any significant findings on physical examination, vital signs, drug tests, ECG, or blood tests at screening that the lead doctor believes could interfere with the trial
• People considered unsuitable by the lead doctor for any other reason

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