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 aged 18 to 50 years of any race or gender.
• For the single-dose part of the trial (Part A): people with a body mass index (a measure of weight relative to height) between 19.0 and 40.0.
• For the multiple-dose part of the trial (Part B): people with a body mass index between 27.0 and 45.0, and a minimum body weight of 50 kg for women and 55 kg for men.
• People whose body weight has been stable (changed less than 5%) for the past 3 months.
• People whose resting heart rate, measured lying down, is between 45 and 90 beats per minute on a heart tracing (ECG) test done at screening.
• Women who could become pregnant, and men, who agree to use contraception as required by the trial during participation.
• Men who agree not to donate sperm, and women who agree not to donate eggs, from one day before the trial starts until 4 months after the last dose.
• People who are able to understand and willing to sign a consent form and follow all trial rules and requirements.

Who may not be able to join:

• People with a significant history or current signs of heart, metabolic, allergy, hormone, kidney, liver, digestive, blood, lung, breathing, skin, nervous system, gynaecological, or psychiatric conditions, as assessed by the trial doctor.
• People with a history of a tumour of the adrenal gland (pheochromocytoma), or whose blood pressure is not well controlled (systolic at or above 160 mmHg or diastolic at or above 100 mmHg).
• People with a history of a tumour of insulin-producing cells (insulinoma), or who have had dangerously low blood sugar within the past year, or have had three or more episodes of low blood sugar symptoms in the past 3 months.
• People who have had a fever or illness within 7 days before their first dose, or who show signs of an active infection.
• People with certain abnormal heart tracing (ECG) results, including specific irregular measurements of heart electrical activity, or a personal or family history of a heart condition called long QT syndrome or related risk factors (confirm with trial site).
• People with a known personal or family history of thyroid tumours, a condition called multiple endocrine neoplasia type 2 (MEN2), thyroid problems, or abnormal thyroid hormone levels.
• People with a history of Type 1 or Type 2 diabetes, or blood test results at screening that suggest diabetes, or who have used blood-sugar-lowering medications in the past 3 months or during screening.
• People with a history of acute or long-term pancreas inflammation (pancreatitis), gallbladder disease with symptoms, pancreatic injury, or other conditions that raise the risk of pancreatitis.
• People with certain abnormal blood test results at screening, including elevated pancreas enzymes (amylase or lipase), elevated liver enzymes (AST or ALT) or bilirubin, very high triglyceride (blood fat) levels, or reduced kidney function (confirm with trial site for specific thresholds).
• People with a history of significant stomach-emptying problems (such as gastroparesis), severe ongoing digestive conditions (such as active ulcers within the past 6 months, active gastritis, uncontrolled acid reflux, irritable bowel, or severe inflammatory bowel disease).
• People who regularly use medications that affect gut movement (such as mosapride or cisapride), or who have had stomach or gut surgery within 12 weeks before screening, if the trial doctor considers this a concern.
• People who test positive for hepatitis B, hepatitis C, or HIV.
• People with a history of serious psychiatric conditions such as major depression, bipolar disorder, or schizophrenia, or a history of suicidal thoughts or attempts within the past 2 years.
• People who currently have any active thoughts of suicide, as assessed using a standard clinical scale (C-SSRS).
• People with a history of alcohol or drug/substance 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), where one unit equals roughly half a pint of beer, a small glass of wine, or a single measure of spirits.
• 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 tobacco product on average, within the 6 weeks before screening.
• Women who are pregnant, breastfeeding, or who have a positive pregnancy test at screening.
• People who cannot tolerate having blood taken through a needle, or who have a history of fainting at the sight of blood or during blood draws, unless the trial doctor considers this acceptable.
• People with a history of severe allergic reactions, including anaphylaxis, cytokine release syndrome, or allergic reactions to multiple medications.
• People with a known or suspected allergy or sensitivity to the trial drug or any of its ingredients.
• People using or planning to use any prescription medicines (other than hormone replacement therapy or contraceptives) within 14 days before dosing, unless the trial doctor considers this acceptable.
• People using or planning to use slow-release medications that would still be active within 14 days before the trial starts, unless the trial doctor considers this acceptable.
• People using or planning to use any non-prescription products, including vitamins, minerals, or herbal supplements, within 7 days before the trial starts, unless the trial doctor considers this acceptable.
• People with a history of serious infectious disease, severe physical injury, or major surgery within 4 weeks before screening, if the trial doctor considers this a concern.
• People who have received a vaccine within 4 weeks before screening, or who plan to receive one during the trial.
• People who have donated blood, had significant blood loss (more than 450 mL), or received blood products within 12 weeks before screening.
• People who have taken part in another clinical trial involving an experimental drug, device, or vaccine, or who have received a biological treatment, within 12 weeks before screening.
• People with poor access to veins for blood draws.
• People who work at the trial site, or their close family members (spouse, parent, child, or sibling).
• People who have any significant findings on physical examination, vital signs, ECG, or blood tests at screening that the trial doctor believes could interfere with the trial.
• People with any skin condition or tattoo at the injection site area that could make it difficult to check for reactions at that site.
• People considered unsuitable for any other reason, at the trial doctor's judgement.

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