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 to 75 years old (inclusive) with a body mass index (BMI) of 24 or above — any gender may apply
• People whose kidneys are working at a reduced but not severely low level, based on a specific kidney function measurement called eGFR (between 45 and below 90 mL/min/1.73m²) — (confirm with trial site)
• People who have had a moderately to severely elevated level of protein in their urine (a measurement called UACR, between 300 and 5000 mg/g) for at least 3 months before the screening stage, confirmed by at least 2 separate tests within 4 weeks of screening
• People who are already taking certain kidney- or blood pressure-related medications (such as SGLT2 inhibitors, ACE inhibitors, ARBs, or MRAs) at a stable dose for at least 4 weeks before screening — or people who are unable to take these medications due to side effects or other medical reasons, if the trial doctor considers participation appropriate
• People who are willing to take part and sign a consent form
• People who are able to have children (both female participants and male participants whose partners could become pregnant) who agree to use effective contraception from the start of the trial until 3 months after the last dose

Who may not be able to join:

• People with a diagnosis of type 1 diabetes or other specific forms of diabetes (not standard type 2 diabetes)
• People with an active, unresolved acute kidney injury at the time of screening
• People who have or have had certain specific kidney conditions, including: narrowing of the arteries supplying both kidneys, kidney inflammation caused by certain diseases, lupus-related kidney disease, inherited kidney cyst diseases (ADPKD or ARPKD), a particular type of blood vessel inflammation affecting the kidneys, removal of one kidney, or other serious kidney structural problems — or people whose kidney disease has been rapidly worsening, as judged by the trial doctor
• People with poorly controlled blood pressure (top number of 160 or higher, and/or bottom number of 100 or higher) at screening
• People with a blood sugar control marker (HbA1c) of 9.5% or above
• People with a history of most cancers within the past 5 years (certain fully cured skin cancers and non-spreading cancers in place may be exceptions — confirm with trial site)
• People who have had a stroke, mini-stroke, brain bleed, blood clot in a deep vein, or similar blood vessel event within the past 6 months
• People who have had a heart attack, or heart procedures such as stenting or bypass surgery, within the past 6 months
• People who have had heart failure classified as severe (NYHA class III or IV) within the past 6 months
• People with certain stomach or digestive conditions, including delayed stomach emptying, blockages in the gut, uncontrolled acid reflux, severe active ulcers, inflammatory bowel disease, or a history of major upper digestive tract surgery
• People with a history of pancreatitis, pancreatic injury, or pancreatic surgery
• People with a history of symptomatic gallstone disease within the past 2 years (people who have had gallstone or gallbladder removal surgery at least 3 months before screening with no ongoing complications may still be considered — confirm with trial site)
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related genetic condition (MEN type 2)
• People who have had a serious diabetes-related emergency (such as diabetic ketoacidosis) within the past 6 months
• People with severe eye conditions related to the back of the eye (such as advanced retinal disease or macular swelling) that the trial doctor judges require urgent treatment
• People with severe long-term diabetes complications — such as serious nerve damage or diabetic foot disease — that the trial doctor believes may affect their safety or ability to follow the trial requirements
• People who have had a severe low blood sugar episode, or repeated episodes of low blood sugar (2 or more times in 6 months), within the past 6 months
• People with thyroid problems that are not well controlled with medication, or who have abnormal thyroid test results at screening that require new treatment
• People with a history of depression or a depression questionnaire score of 15 or above at screening, or a history of serious mental health conditions including suicidal thoughts or attempts, schizophrenia, or bipolar disorder
• People who have taken certain diabetes medications in the 3 months before joining, including DPP-4 inhibitors, GLP-1 medicines, GIP medicines, amylin analogues, or glucagon analogues
• People who have used systemic steroid or immune-suppressing medications within the past 3 months (some short-term or localised uses may be exceptions — confirm with trial site)
• People who have used over-the-counter weight loss products, appetite-suppressing supplements (including some traditional herbal medicines), or fat-dissolving injection treatments within the past 3 months
• People whose screening blood tests show certain abnormal results, including: severe anaemia, significantly abnormal liver function, low blood protein (albumin), high potassium levels, very high triglycerides (blood fats), abnormal blood clotting measures, elevated calcitonin (a thyroid marker), elevated pancreatic enzymes, or active hepatitis B, hepatitis C, HIV, or untreated syphilis infection
• People with certain abnormal heart rhythm findings on an ECG at screening, including specific types of heart block, long QT syndrome, abnormal QT intervals, pre-excitation syndrome, other serious arrhythmias, or a heart rate below 50 or above 110 beats per minute
• People whose body weight changed by more than 5% in the 6 weeks before screening
• People who have had or are planning to have weight loss (bariatric) surgery
• People with a history of alcohol or drug misuse
• People who are allergic to the study drug or any of its ingredients
• People who have taken part in another clinical trial within 30 days before screening, or within 5 half-lives of an investigational drug (whichever is longer) — observation-only studies or screening-only participation without receiving medication may be exceptions (confirm with trial site)
• People who are currently on dialysis or have had a kidney transplant, or who plan to have either during the study
• People who are pregnant or breastfeeding
• People whom the trial doctor considers unsuitable for any other reason

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