A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants (NCT07011797) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
United States250 participantsStarted 2025-06-17
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study:
* To evaluate the efficacy of different dose levels of CX11 tablets in body weight reduction as compared to placebo.
* To compare the changes of effects in weight and weight-related indicators at the visit time points.
* To evaluate the tolerability and safety of different doses of CX11 tablets in overweight/obese participants.
* To assess the pharmacokinetics (PK) of different doses of CX11 tablets in overweight/obese participants.
Overweight/obese participants who are successfully screened will be randomized in a 1:1:1:1:1 ratio to different doses of CX11 tablets or placebo. All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.
Who can participate
Age range
18 Years – 75 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
Participants who meet all of the following criteria will be eligible to participate in this study:
* Between 18 and 75 years old. Both men and women can participate, but women may make up to 70% of the participants.
* BMI of 30 or higher, or a BMI between 27 and 30 with at least one related health condition such as prediabetes, high blood pressure, abnormal cholesterol levels, fatty liver, or sleep apnea due to being overweight.
* HbA1c level below 6.5% and fasting blood sugar levels below 126 mg/dL.
* Have tried and failed to lose weight through diet and exercise at least once before the study and must have had a stable body weight (less than a 5% change) in the 90 days before the study.
* Participants and their partners must not plan to become pregnant or donate sperm/eggs during the study and for 90 days after. They must agree to use effective contraception for at least 6 months prior to screening and continue their chosen contraception method throughout the study. Women who could become pregnant must have a negative pregnancy test 24 hours before the first dose of study drug.
* Willing to maintain a stable diet and exercise routine during the study and keep a diary of their activities.
* Understand the study procedures, be willing to follow the study rules strictly, and sign a consent form voluntarily.
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from this study:
* Known or suspected hypersensitivity to GL…
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.