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 are male and between 18 and 55 years old (inclusive)
• People whose body mass index (BMI) falls between 24.0 and below 35.0 (a measure of body weight relative to height)
• People whose blood sugar control levels are within a specific healthy range — specifically, an HbA1c (a 3-month average blood sugar measure) below 6.5%, and a fasting blood glucose level between 3.9 and below 7.0 mmol/L
• People who are willing and able to follow all study procedures and restrictions for the full duration of the trial, and who are willing to sign a formal consent form

Who may not be able to join:

• People who have a history of, or currently have, significant ongoing health conditions affecting the heart, lungs, hormones, kidneys, digestion, blood, immune system, nerves, or mental health, or who have had a bacterial or viral infection
• People with a history of pancreatitis (acute or long-term), medullary thyroid cancer (personal or family history), a hereditary condition called multiple endocrine adenoma syndrome type 2, or any other cancer history
• People with a history of digestive system disorders such as reflux, gallbladder disease, conditions that affect how quickly the stomach empties (such as prior gastric bypass surgery or pyloric stenosis), or conditions that could be worsened by certain diabetes-related drug types (note: prior appendectomy is not excluded)
• People who have had gallstones treated or their gallbladder removed in the past
• People with known allergies to the ingredients in the study drug (KN069), or to similar drugs in the same drug category
• People who have misused or been dependent on medications or illegal drugs within the year before screening, or whose urine drug test comes back positive
• People who have had major surgery within 3 months before screening, or who have surgery planned during the trial — where "major surgery" means operations involving the head, chest, abdomen, pelvis, or limbs that cause significant tissue injury and require lengthy recovery
• People who have been drinking more than 14 units of alcohol per week in the 3 months before or during screening, or who are unable to stop drinking alcohol during their hospital stay, or unable to limit alcohol to fewer than 2 units per day during follow-up visits after discharge
• People who have donated blood or lost 300 mL or more of blood within 3 months before screening, or who plan to donate blood or blood products during the trial or within 1 month after the final study visit
• People who have taken part in another clinical trial of a drug or vaccine within 2 months before screening, or who are currently enrolled in another clinical trial
• People who have been following a strict diet or weight loss programme, or who have made major changes to their lifestyle habits, within 2 months before the first dose
• People who have received any vaccine within 14 days before screening, or who have a vaccination scheduled during the trial (this includes all vaccine types, including COVID-19 vaccines)
• People who have taken any medication — including prescription drugs, over-the-counter medicines, or herbal products — within 14 days before dosing, with the exception of vitamin or mineral supplements, paracetamol, creams or ointments applied to the skin, and contraceptives
• People who have used GLP-1 related medications or other incretin-related drugs within 3 months before dosing, or any other medications the trial doctor believes could affect the results
• People whose blood test results during screening show liver enzyme levels more than twice the normal upper limit, bilirubin levels more than 1.5 times the normal upper limit, or fasting triglyceride levels at or above 5.6 mmol/L — or whose physical examination, vital signs, heart tracing (ECG), lab tests, or imaging show results considered clinically significant by the investigator
• People whose breath test shows any detectable alcohol at screening
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who test positive for drug misuse on a urine screen
• People who are unwilling to abstain from fathering a child, or who are unwilling to use a highly effective form of contraception consistently from the time of signing the consent form through to 3 months after receiving the study drug — or who have plans for conception during this period
• People who plan to donate sperm from the time of dosing until 3 months after receiving the study drug
• People whose abdominal skin is not suitable for injection under the skin due to injury, surgery, allergies, or skin conditions in that area
• People whom the trial investigator considers unsuitable for participation for any other reason

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