Phase 2 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:

• People aged 18 or older at the time of signing the consent form
• People with a BMI of 28 or higher
• People whose heart failure symptoms fall into a moderate category (NYHA Class II or III) (confirm with trial site)
• People who have not been hospitalised due to heart failure between the initial screening visit and the randomisation visit
• People whose heart failure symptom score (measured by a questionnaire called the KCCQ-CSS) is below 80 during the screening period
• People whose medications for ongoing conditions have been at a stable dose for at least 4 weeks before the trial starts, or who have not been taking such medications for at least 4 weeks
• Women who could become pregnant must agree to use the contraception method specified by the trial, test negative for pregnancy during screening, and not be breastfeeding during the study or for 3 months after the final treatment
• People who are willing to follow all study requirements throughout the trial, including keeping diet and exercise habits stable, taking the study medication as planned, and keeping a study diary

Who may not be able to join:

• People who have had a heart attack, stroke, or mini-stroke, or who were hospitalised for severe heart failure requiring mechanical or circulatory support devices, within the 3 months before screening
• People who have had unstable chest pain or worsening heart failure requiring intravenous medications within the 30 days before screening
• People with poorly controlled blood pressure — specifically a top reading of 160 mmHg or higher, a bottom reading of 100 mmHg or higher, or a top reading below 90 mmHg at screening
• People who have previously had weight-loss (bariatric) surgery, or who plan to have it during the study period
• People who have a hormone-related (endocrine) condition or history of one that could significantly affect body weight
• People previously diagnosed with Type 1 diabetes or certain other specific types of diabetes
• People who have used certain diabetes or weight-related injectable medications (GLP-1, GLP-1/GCGR, or GIP receptor agonists) within 3 months before screening, or who stopped using them more than 3 months before screening due to the medication not working or causing intolerance
• People who have used insulin to manage diabetes in the 3 months before screening, except for short-term use of 14 days or less during an acute illness or surgery — provided the last insulin dose was at least 14 days before the screening date
• 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 2A or 2B)
• People with a significant condition affecting how the stomach empties, such as severe diabetic gastroparesis or a blocked stomach outlet, or who have had certain gastrointestinal surgeries
• People who have had an active or untreated cancer within the past 5 years, or whose cancer is in remission — with some exceptions for certain skin cancers, cervical carcinoma in situ, prostate carcinoma in situ, or papillary thyroid cancer with no recurrence after surgery (confirm with trial site)
• People with a history of serious allergic reactions or severe reactions to multiple medications, including serious skin reactions or anaphylaxis
• People who have had an organ transplant (except corneal or autologous skin grafts), or who are planning to receive one
• People who may be planning major surgery during the study that could affect their ability to walk
• People with a history of suicidal thoughts or behaviour
• People whom the trial investigators consider unsuitable for any other reason, including a history of serious mental illness

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