A Phase 1b Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of TQF3250 Capsules in Trial Participants With Type 2 Diabetes Mellitus Complicated With Overweight or Obesity
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.
• 1.Aged between 18 and 70 years, inclusive.
• 2.Able to provide written informed consent, and meet the following requirements:
‣ 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.
• 3.Diagnosed with type 2 diabetes mellitus combined with overweight or obesity at screening, in accordance with the 1999 WHO diagnostic criteria.
• 4.Females of childbearing potential must agree to use effective contraceptive measures throughout the study period and for 6 months after study completion (Note: Oral hormonal contraceptives shall not be relied upon as the sole contraceptive method), and have a negative serum pregnancy test result within 7 days prior to study enrollment. Male subjects must agree to use effective contraceptive measures throughout the study period and for 6 months after study completion.