A Clinical Trial Evaluating TQF3250 Capsules in Patients With Type 2 Diabetes Mellitus and Overwe… (NCT07747857) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Trial Evaluating TQF3250 Capsules in Patients With Type 2 Diabetes Mellitus and Overweight/Obesity
China72 participantsStarted 2026-09
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical study designed to evaluate the safety, tolerability, pharmacokinetic profiles and preliminary efficacy of multiple oral doses of TQF3250 capsules in trial subjects with type 2 diabetes mellitus complicated with overweight or obesity. A total of 72 eligible subjects are planned to be enrolled in this study.
Six treatment dose groups are established, including 4 mg, 8 mg, 12 mg, 24 mg, 32 mg and 40 mg, with a dose-escalation titration design. Each dose group will consist of 12 subjects. Eligible screened subjects will be randomized at a ratio of 10:2 (10 subjects receiving investigational drug and 2 subjects receiving placebo) to receive treatment with either TQF3250 capsules or matching placebo.
Who can participate
Age range
18 Years – 70 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
. Voluntarily participate in the study and capable of signing the informed consent form;
. Willing and able to complete all study-specified procedures and study visits. Subjects who fail to comply with the treatment regimen, diabetic diet, and exercise program formulated by the investigator, or who are unwilling or unable to perform self-monitoring of blood glucose, shall be excluded.
Exclusion criteria
. Diagnosed with or suspected of type 1 diabetes mellitus, specific types of diabetes, or secondary diabetes mellitus;
. Occurrence of acute diabetic complications within 6 months prior to screening;
. Medical history of severe hypoglycemic coma; occurrence of severe hypoglycemic episodes or recurrent hypoglycemic events within 6 months prior to screening;
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.
1Since TQF3250 is in Phase 1, this trial is mainly focused on safety rather than proving it works — so what does that mean for me as someone who also needs to manage my blood sugar and weight right now?
2This trial isn't recruiting yet, so is there any value in me expressing interest early, or would it make more sense to wait and see what the initial safety data looks like before considering it?
3The trial is specifically measuring adverse events and abnormal clinical findings — based on what you know about how this type of drug works, what kinds of side effects should I be most aware of going into a conversation like this?
4Given that I have both Type 2 diabetes and overweight or obesity, are there standard treatments or combination therapies already available that might address both conditions while this early-phase trial is still getting started?
5If I were ever to consider a Phase 1 trial like this one, how would participation affect my current diabetes management plan, and would I need to pause or change any medications I'm already taking?
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
Adverse Event
Timeframe: Baseline up to 14 weeks
2
Abnormal clinical examination findings
Timeframe: Baseline up to 14 weeks
Trial details
NCT IDNCT07747857
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. Presence of proliferative retinopathy or macular lesions requiring acute treatment, painful diabetic neuropathy, diabetic foot or intermittent claudication confirmed by ophthalmic examination or medical records within 90 days prior to randomization;
. Presence of diseases judged by the investigator to be clinically significant and likely to compromise subject safety, interfere with study drug metabolism, or confound evaluation of study outcomes, including but not limited to diseases of the nervous, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, hematological and immune systems (excluding complications related to type 2 diabetes mellitus).
. Any condition that may interfere with drug absorption;
. Concurrent hyperthyroidism, Cushing's syndrome, diabetic gastroparesis or other diseases associated with gastric emptying disorders, gastrointestinal diseases assessed by the investigator to increase postdosing risks, anorexia nervosa, alcohol dependence, drug abuse, substance dependence, epilepsy, psychiatric disorders, or conditions requiring systemic antiinfective treatment. Subjects with subclinical hypothyroidism or well-controlled hypothyroidism under stable medication are eligible for enrollment;
. Medical history of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association (NYHA) Class II-IV heart failure, or transient ischemic attack within 6 months prior to screening; or medical history of clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic medication;