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)
• People with a Body Mass Index (BMI) between 27.0 and 35.0 kg/m² at the time of screening
• People whose weight has stayed within 5% (up or down) over the 3 months before screening, using only diet and exercise (self-reported)
• People who agree not to try to conceive a child during the study and for 3 months after the last dose, and who agree to use effective contraception and not donate sperm or eggs during that time (this applies to all participants, including males)
• People with a negative HIV antibody test result at screening
• People who fully understand what the trial involves, are willing to take part, can communicate well with the research team, and agree to sign a consent form before any study procedures begin

Who may not be able to join:

• People who have been diagnosed with type 1, type 2, or any other form of diabetes
• People whose obesity has been caused by a genetic condition or a medical condition such as thyroid problems, Cushing's syndrome, a tumour affecting insulin, or hormone-related conditions
• People who have had weight-loss (bariatric) surgery in the past, with some exceptions for certain procedures done more than 1 year ago (confirm with trial site), or who plan to have bariatric surgery or use weight-loss devices during the study
• People who have used weight-loss medications (such as liraglutide, semaglutide, orlistat, or similar drugs), herbal weight-loss supplements, meal replacements, or weight-loss capsules in the 3 months before screening
• People who have used a class of diabetes or weight-related medications called GLP-1 receptor agonists, or related combination drugs, in the 3 months before screening
• People who have used diabetes medications such as metformin, SGLT2 inhibitors, insulin, or similar drugs in the 3 months before screening
• People who have used certain other medications known to affect body weight in the 3 months before screening, including some antidepressants, antipsychotics, anti-epilepsy medicines, or antihistamines; or systemic steroid treatment for more than 1 week
• People who have used any experimental drugs, vaccines, or medical devices in the 3 months before screening
• People whose blood test results at screening show blood sugar levels, liver enzyme levels, kidney function, thyroid hormone levels, triglyceride levels, digestive enzyme levels, calcitonin levels, or other markers outside the acceptable ranges specified by the trial (confirm with trial site for specific values)
• People with high blood pressure that is not well controlled (systolic at or above 160 mmHg and/or diastolic at or above 100 mmHg)
• People whose heart rhythm test (ECG) shows certain abnormalities, including a very slow or fast heart rate, certain types of heart block, long QT syndrome, or other significant heart rhythm problems
• People with a history of acute or long-term pancreatitis (inflammation of the pancreas), or ongoing gallbladder problems (except those who have had their gallbladder removed)
• People with clinically significant findings during a nasal examination, as judged by the investigator
• People who have had nasal or sinus surgery, or a nasal injury, within the 3 months before screening that has not fully healed
• People with nasal conditions such as nasal sores, a hole in the nasal septum, sinusitis, allergic rhinitis, nasal polyps, or other problems that could affect how a nasal medication is absorbed
• People with large scars or tattoos on the abdomen, thighs, or upper arms that could interfere with how the study drug is given
• People with a history of thyroid disease or abnormal thyroid function that has required treatment and is considered clinically significant
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related inherited condition (multiple endocrine neoplasia type 2)
• People who have been diagnosed with any cancer in the past 5 years, with some exceptions for certain fully treated cancers (confirm with trial site)
• People who have had a heart attack, heart bypass or stent procedure, valve surgery, stroke, mini-stroke (TIA), unstable chest pain, or significant heart rhythm problems requiring treatment within 6 months before screening; or people with severe heart failure (NYHA Class III or IV)
• People with significant digestive conditions at or around the time of screening, such as a blocked stomach outlet, bowel obstruction, delayed stomach emptying, inflammatory bowel disease, severe acid reflux, or an active stomach ulcer
• People who test positive for hepatitis B, hepatitis C, or syphilis at screening
• People who have had an upper respiratory tract infection (such as a cold) within 7 days before the study drug is due to be given
• People who have had a major depressive disorder or other serious psychiatric illness within the 2 years before screening, or who have any history of self-harm or suicidal behaviour, or who have active suicidal thoughts of a serious nature as measured by a standard assessment tool
• People who have donated blood in the 3 months before screening, or who have lost 400 mL or more of blood in the 6 months before screening (not counting normal menstruation), or who plan to donate blood within 3 months after the study ends
• People with a history of fainting at the sight of needles or during blood draws, or who cannot tolerate having a needle placed in a vein
• People with a known allergy or sensitivity to GLP-1 receptor agonist medications or to any ingredient in the study drug
• People who have consumed more than 14 units of alcohol per week on average in the year before screening, or who are not willing to avoid alcohol during the study, or who test positive on a breath alcohol test at check-in
• People who smoke more than 5 cigarettes per day and have done so in the 3 months before screening, or who are not willing to avoid smoking during the study
• People with a history of drug misuse or non-medical use of controlled substances in the year before screening, or who test positive for certain substances (such as opioids, methamphetamine, MDMA, or cannabis) at screening
• People who are pregnant, breastfeeding, or who test positive on a pregnancy test at screening or at check-in
• People whom the investigator considers unsuitable for any other reason

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