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.
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.
1.Other diabetic conditions besides type 2 diabetes mellitus
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;
Parallel
TQF3250 capsules
DrugAn oral glucagon-like peptide-1 receptor agonist.
TQF3250 placebo
DrugTQF3250-matched placebo capsules.
Adverse Event
Incidence and Severity of All Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs).
Abnormal clinical examination findings
Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram,etc.
Area Under the Curve from 0 to 24 hours(AUC0-24h)
AUC0-24h following the first administration at target dose, and AUC0-24h after multiple administrations.
Area Under the Curve from time zero to infinity(AUC0-∞)
AUC0-∞ following the first administration at target dose, and AUC0-∞ after multiple administrations.
Area Under the Curve from time zero to the last quantifiable time point(AUC0-t)
Area Under the Curve from time zero to the last quantifiable time point(AUC0-t).
Maximum Plasma Concentration(Cmax)
Cmax following the first administration at target dose.
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