Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants (NCT07765160) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants
China96 participantsStarted 2026-08-30
Plain-language summary
Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.
Who can participate
Age range
18 Years – 65 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:
All participants in Part A (SAD) and Part B (MAD) must meet inclusion criteria 1-3:
* 1.The age at the time of informed consent should be between 18 and 65 years old (including both values), and there is no gender restriction.
* 2.Female participants who are fertile and male participants whose partners are fertile must agree to use the contraceptive methods specified in the protocol during the study period and within 90 days after the last administration. The pregnancy test results of female participants with fertility before randomization must be negative. Female participants should not breastfeed. Male/female participants must be willing to avoid donating sperm/eggs during the study period and within 90 days after the last administration.
* 3\. Be able to understand the procedures and methods of this research, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
Participants of Part A (SAD) also need to meet inclusion criteria 4-6:
* 4\. Participants who were determined by the researchers to be normal or abnormal based on the results of various examinations such as medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, infectious disease screening, chest X-ray, and abdominal color Doppler ultrasound, but were determined by the researchers to have no clinical significance.
* 5\. During screening, 20 kg/m ² ≤BMI \<28 kg/m ²;
* 6\. When…
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
SAD: The incidence rate of adverse events (AE)
Timeframe: through study completion, an average of 60 days
2
SAD: The incidence rate of serious adverse events (SAE)
Timeframe: through study completion, an average of 60 days
3
SAD: Number of subjects with clinically significant changes in physical examination results
Timeframe: through study completion, an average of 60 days
4
SAD: Number of subjects with clinically significant changes in vital signs
Timeframe: through study completion, an average of 60 days
5
SAD: Number of participants with abnormal laboratory tests results
Timeframe: through study completion, an average of 60 days
6
SAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram
Timeframe: through study completion, an average of 60 days