A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Particip… (NCT07716241) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Participants
China92 participantsStarted 2026-09-22
Plain-language summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged between 18 and 55 years (inclusive) at screening, male or female.
. Participants must fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the informed consent form (ICF) prior to any study-related procedures.
. Agree to use effective contraceptive measures and refrain from sperm or egg donation from the time of signing the ICF until 4 months after the last dose.
. Agree to abstain from alcohol, smoking, and food or beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.), and refrain from strenuous exercise from 48 hours prior to dosing until discharge from the study site.
. Self-reported body weight fluctuation of ≤ 5.0% within 12 weeks prior to screening through diet and exercise control alone.
. Willing and able to maintain a stable diet and exercise lifestyle throughout the study period.
. SAD cohort: body weight ≥ 50 kg, BMI 19.0-28.0 kg/m² (inclusive). MAD cohort: BMI 28.0-40.0 kg/m² (inclusive).
Exclusion criteria
. History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, psychiatric, neurological, hematological, immunological, or metabolic disorders (e.g., recurrent hypoglycemia of unknown cause) that, in the investigator's opinion, would make the participant unsuitable for participation in this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse Events
Timeframe: Start of Treatment to end of study (approximately 57 days or 112 days)
. Clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
. Presence of diseases that, in the investigator's judgment, may significantly affect drug or nutrient absorption, including clinically significant gastrointestinal disorders (e.g., active inflammatory bowel disease) or symptoms of gastrointestinal disturbance; or any condition that may affect drug absorption, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, or resection of any intestinal segment.
. Diagnosis of chronic pancreatitis or history of idiopathic acute pancreatitis, or serum amylase or lipase above the upper limit of normal (ULN) at screening. Participants with a history of acute pancreatitis due to cholelithiasis may be enrolled if they have undergone cholecystectomy.
. History of acute cholecystitis, or presence of symptomatic/stone-related cholelithiasis requiring treatment on prior or screening ultrasound (except for participants who have undergone cholecystectomy and are deemed eligible by the investigator).
. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2), or screening calcitonin level ≥ 50 ng/L.
. Participation in any other clinical trial of a drug or medical device within 3 months prior to screening (excluding those who did not receive the investigational product or device).
. History of diabetes mellitus (type 1, type 2, or rare forms of diabetes).