This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical study. All trial participants are required to use TQF3250 capsules or placebo. The aim is to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of multiple administrations of TQF3250 capsules. A total of 80 trial participants are required.
During screening, trial participants must be aged 18 to 65 (inclusive), and can be male or female;
During screening, obese individuals with a BMI of 28 to less than 40 kg/m2, or overweight individuals with a BMI of 24 to less than 28 kg/m2 accompanied by at least one of the weight-related comorbidities.
According to the self-reported information of the trial participants, they had undergone at least 3 months of simple lifestyle intervention before screening, and their weight change in the past 3 months was less than 5%.
Women of childbearing age should agree to take effective contraceptive measures during the study period and for 6 months after its completion (note: oral hormonal contraceptives should not be relied upon solely for contraception), and they must have a negative blood pregnancy test within 7 days prior to study enrollment; men should agree to take effective contraceptive measures during the study period and for 6 months after its completion.
Trial participants whom researchers suspect may be allergic to the study drug or its components, or who have an allergic constitution;
Participants who have used glucagon-like peptide-1 receptor (GLP-1R) agonists, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) agonists, or GLP-1R/glucagon receptor (GCGR) agonists within the previous 3 months prior to screening;
Screen for medications that have been used or are currently being used within the previous 3 months and have an impact on body weight, including: steroid hormone medications (administered intravenously, orally, or intra-articularly), metformin, sodium-glucose co-transporter 2 (SGLT-2) inhibitors, thiazolidinediones (TZD), tricyclic antidepressants, medications for psychiatric disorders or sedatives (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts), etc;
Screen for individuals who have consumed Chinese herbal medicines, health supplements, or meal replacements that affect body weight within the previous 3 months;
Parallel
TQF3250 capsules
DrugAn oral glucagon-like peptide-1 receptor agonist
TQF3250 placebo
DrugPlacebo contains no active substance.
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)
AUC0-t after multiple administrations
Maximum Plasma Concentration(Cmax)
Cmax following the first administration at target dose
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This trial is not recruiting at the moment. You can still explore other options:
