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:

• People who fully understand what the study involves, including its procedures and possible risks, and are willing to follow the study rules and sign a consent form.
• Adults aged 18 to 75 years old at the time of signing the consent form.
• People who weigh at least 50 kg (if male) or at least 45 kg (if female), with a body mass index (BMI) between 19.0 and 32.0.
• People who are not planning to have children during the study and for 8 weeks after the last dose, and who are willing to use effective contraception throughout that time; women who could become pregnant must not be pregnant or breastfeeding, must have a negative pregnancy test at the screening visit, and must not have had unprotected sex in the 2 weeks before screening.
• People in the liver dysfunction group: those with long-term liver disease caused by viral hepatitis, alcohol-related liver disease, autoimmune hepatitis, or other reasons, where the condition is assessed by the study doctor as not rapidly getting worse.
• People in the liver dysfunction group: those whose liver disease has been graded as Child-Pugh A, B, or C, and who have not received albumin treatment in the 21 days before screening.
• People in the liver dysfunction group: those assessed by the study doctor as being in a suitable physical condition to participate, based on medical history, physical checks, vital signs, blood and urine tests, heart tracing (ECG), chest X-ray, and ultrasound.
• People in the normal liver function group: those whose age, sex, weight, and BMI closely match participants in the liver dysfunction group (confirm with trial site for exact matching criteria).
• People in the normal liver function group: those whose test results — including blood tests, vital signs, physical examination, ECG, chest X-ray, and ultrasound — are normal, or are considered by the study doctor to have no meaningful health significance.

Who may not be able to join:

• People with a history of severe drug allergies or hypersensitivity reactions, or who are known to be allergic to the study drug, GLP-1 type drugs, or any of the study drug's ingredients (including citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid, or sodium hydroxide).
• People with a history of acute or chronic pancreatitis or pancreatic injury, or who have a gallbladder condition causing symptoms at the time of screening.
• People with a personal or close family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a condition called multiple endocrine neoplasia type 2A or 2B.
• People who have had certain serious heart or stroke-related conditions in the 6 months before screening, including severe heart failure, unstable chest pain, heart attack, heart valve replacement surgery, bypass or other major heart procedures, or a stroke or mini-stroke.
• People whose heart tracing (ECG) at screening shows a QTcF reading above 470 milliseconds (for males) or above 480 milliseconds (for females).
• People who have had a serious active infection in the month before screening.
• People who have been diagnosed with a malignant cancer in the past 5 years, with the exception of certain skin cancers (basal cell or squamous cell carcinoma) or cervical cancer in its earliest stage.
• People who have had a serious injury, stomach or bowel surgery, or other major surgery in the 4 weeks before screening.
• People who are unwilling or unable to follow the study procedures, or who the study doctor considers unsuitable for participation for any reason.

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