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A Clinical Trial of TQF3250 Capsules in Overweight/Obese Trial Participants With Poor Weight Control Through Simple Lifestyle Intervention

27 de agosto de 2026 actualizado por: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase 1b Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of TQF3250 Capsules in Overweight/Obese Trial Participants With Poor Weight Control Through Simple Lifestyle Intervention

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Linong Ji, Doctor
  • Número de teléfono: 13910978815
  • Correo electrónico: jiln@bjmu.edu.cn

Ubicaciones de estudio

  • Porcelana
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100000
        • Peking University People's Hospital
        • Contacto:
          • Linong Ji, Doctor
          • Número de teléfono: 13910978815
          • Correo electrónico: jiln@bjmu.edu.cn
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510000
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contacto:
          • Meng Ren, Doctor
          • Número de teléfono: 13729807880
          • Correo electrónico: renmeng80@139.com
        • Contacto:
          • Mingtong Xu, Doctor
          • Número de teléfono: 13719335149
          • Correo electrónico: xumtong@126.com
      • Guangzhou, Guangdong, Porcelana, 510000
        • Guangzhou First People's Hospital
        • Contacto:
          • Suiqin Ni, Master
          • Número de teléfono: 18933962556
          • Correo electrónico: n_sql@126.com
        • Contacto:
          • Ling He, Doctor
          • Número de teléfono: 18122208619
          • Correo electrónico: 2518061377@qq.com
    • Henan
      • Zhengzhou, Henan, Porcelana, 450003
        • Zhengzhou People's Hospital
        • Contacto:
          • Yong Last Name 姓 Tian 田, Master
          • Número de teléfono: 13673686680
          • Correo electrónico: 47679410@qq.com
    • Hubei
      • Wuhan, Hubei, Porcelana, 430000
        • Zhongnan Hospital of Wuhan University
        • Contacto:
        • Contacto:
          • Jianying Huang, Doctor
          • Número de teléfono: 18971116998
          • Correo electrónico: znyylcsy@126.com
      • Xianning, Hubei, Porcelana, 437100
        • Xianning Central Hospital
        • Contacto:
          • Fangliang Gan, Master
          • Número de teléfono: 13387170096
          • Correo electrónico: ganfang9876@163.com
    • Shandong
      • Jinan, Shandong, Porcelana, 250013
        • Central Hospital Affiliated to Shandong First Medical University
        • Contacto:
          • Qing Wen, Master
          • Número de teléfono: 13370551767
          • Correo electrónico: wenq0619@163.com
        • Contacto:
          • Xiaolin Dong, Doctor
          • Número de teléfono: 15318816218
          • Correo electrónico: 13969198540@163.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200072
        • Shanghai Tenth People's Hospital
        • Contacto:
          • Haibing Chen, Doctor
          • Número de teléfono: 18930173813
          • Correo electrónico: 18930173813@163.com
        • Contacto:
          • Jun Li, Doctor
          • Número de teléfono: 18930560396
          • Correo electrónico: lijundfgd1@163.com
    • Sichuan
      • Luzhou, Sichuan, Porcelana, 646000
        • The Affiliated Hospital of Southwest Medical University
        • Contacto:
          • Qin Wan, Master
          • Número de teléfono: 13882746971
          • Correo electrónico: 494039830@qq.com
        • Contacto:
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 311201
        • The First People's Hospital of Xiaoshan Hangzhou
        • Contacto:
          • Jun Chen, Master
          • Número de teléfono: 15925676818
          • Correo electrónico: 64774630@qq.com
        • Contacto:
          • Jian Chen, Doctor
          • Número de teléfono: 13588084969
          • Correo electrónico: cj21_0503@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Key inclusion criteria:

    1. During screening, trial participants must be aged 18 to 65 (inclusive), and can be male or female;
    2. 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.
    3. 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%.
    4. 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.
    5. Volunteer to sign the informed consent form and are willing to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire research period, including but not limited to: managing diet and exercise lifestyle, taking the study medication as scheduled, keeping a research diary, and completing relevant questionnaires.

Exclusion Criteria:

  • Key exclusion criteria:

    1. Trial participants whom researchers suspect may be allergic to the study drug or its components, or who have an allergic constitution;
    2. 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;
    3. 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;
    4. Screen for individuals who have consumed Chinese herbal medicines, health supplements, or meal replacements that affect body weight within the previous 3 months;
    5. Screen for individuals who have used or are currently using weight-loss drugs within the previous 3 months, such as: sibutramine hydrochloride, orlistat, phenylbutyrate, phenylpropanolamine, clobenzolide, phentermine, amfepramone, lorcaserin, phentermine/topiramate combination, naltrexone/bupropion combination, etc;
    6. Participants who have participated in other clinical trials (and have received trial drug treatment) within the previous 3 months;
    7. Patients with previously diagnosed diabetes (including type 1 or type 2 diabetes, etc.);
    8. Screen for patients with fasting venous blood glucose levels ≥7.0 mmol/L or glycated hemoglobin levels ≥6.5%;
    9. Participants who have experienced unexplained hypoglycemic events (blood glucose <3.9 mmol/L) within the previous 1 month before screening;
    10. Have previously undergone or plan to undergo weight loss surgery during the study period (excluding acupuncture and moxibustion for weight loss, liposuction, or abdominal liposuction performed more than 1 year before screening);
    11. Obesity caused by secondary diseases or medications, including: elevated cortisol hormone levels (e.g., Cushing's syndrome), obesity caused by pituitary and hypothalamic damage, and obesity caused by diagnosed monogenic or syndromic conditions (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome);
    12. Any clinically significant endocrine system disease (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.) that the investigator deems unsuitable for participation in the study (if the investigator deems the condition stable, and the aforementioned diseases have been stably treated with medication for more than 3 months, and are not expected to have a significant impact on body weight, enrollment may be allowed);
    13. Previous history of depression; suicidal tendencies or suicide attempts, or previous history of severe mental illnesses, such as schizophrenia, bipolar disorder, etc;
    14. Resting blood pressure: Systolic Blood Pressure≥ 160 mmHg or < 90 mmHg, and/or diastolic blood pressure≥ 100 mmHg (a retest is allowed after 10 minutes, and the retest value shall prevail), or new/changed antihypertensive medications or adjusted antihypertensive medication doses within 4 weeks before screening;
    15. Having any malignant tumor within the past 5 years (excluding basal cell carcinoma that has undergone curative treatment and is considered cured);

    16. Before screening, individuals with a history of major cardiovascular and cerebrovascular diseases within the past 6 months are defined as:

      1. History of myocardial infarction, unstable angina, coronary artery angioplasty or bypass surgery, valvular heart disease or valvular heart surgery, clinically significant arrhythmia, transient ischemic attack, or cerebrovascular accident; or
      2. Congestive heart failure with New York Heart Association (NYHA) classification of III or IV;
    17. Screen for hemorrhagic or ischemic stroke or transient ischemic attack that occurred within the previous 6 months;
    18. Individuals with a history or family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B, or genetic diseases that are prone to induce medullary thyroid cancer during screening;
    19. During screening, patients with a history of acute or chronic pancreatitis, pancreatic injury, or clinically significant gallbladder or bile duct diseases (excluding gallbladder polyps that do not require clinical intervention) are excluded;
    20. Previously had clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcer within 6 months before screening), long-term use of drugs with direct effects on gastrointestinal motility, or underwent gastrointestinal surgery (excluding endoscopic resection of gastrointestinal polyps, etc.);
    21. Individuals with physical deformities or mutilations, making it impossible to accurately determine their height, weight, and other indicators;
    22. Participants who have undergone major or medium-sized surgery, severe trauma, or severe infection within one month prior to screening, and are deemed unsuitable for participation in this study by the investigator;
    23. History of organ transplantation, or history of other acquired or congenital immune system diseases;
    24. During the trial, there were anticipated surgeries, except for outpatient surgeries that the researchers determined had no impact on the safety of trial participants and the trial results;
    25. During screening, if the virological test indicates any of the following conditions:
    1. HCV antibody is positive, and the detection value of HCV viral load (HCV RNA) exceeds the upper limit of normal range;
    2. HBsAg is positive, and the HBV DNA detection value exceeds the upper limit of normal range;
    3. HIV-positive;
    4. Active syphilis: Treponema pallidum antibody is positive during the screening period, and the non-treponemal serological test is also positive.

    26. Screen for individuals who have received or plan to receive live vaccines or attenuated live vaccines within 30 days prior to the study. Inactivated vaccines (including inactivated influenza vaccines) are not subject to this restriction, but the vaccination status should be accurately recorded.

    27. Screen for individuals who have regularly consumed alcohol within the previous 3 months, specifically those who have consumed more than 14 units of alcohol per week (1 unit equals 360 mL of beer, 45 mL of spirits with 40% alcohol content, or 150 mL of wine); or those who have exhibited clinically significant abnormalities in blood alcohol testing during the screening period; or those who are unable to adhere to the protocol's prohibition on alcohol consumption; 28. Screen out smokers who have smoked more than 10 cigarettes per day for the previous 3 months or who cannot quit smoking during the pharmacokinetic intensive blood sampling period; 29. Individuals with a history of drug abuse, drug dependence, or use of drugs within the previous year, or those who tested positive for drugs in urine screening prior to drug administration, shall be screened out; 30. During screening, serum calcitonin should be ≥20ng/L; 31. During screening, the alanine aminotransferase (ALT) level must be ≥2.0× ULN and/or the aspartate aminotransferase (AST) level must be ≥2.0× ULN and/or the total bilirubin level must be ≥1.5× ULN and/or the alkaline phosphatase (ALP) level must be ≥2.0× ULN; 32. During screening, the glomerular filtration rate (eGFR) should be less than 60 mL/min/1.73 m2, calculated according to the CKD-EPI 2021 formula; 33. Screen for participants with fasting triglyceride levels ≥5.65 mmol/L (500 mg/dl). If the participants are undergoing lipid-lowering treatment, the type and dosage of medication should be stable for at least 30 days before screening, and in principle, they should remain unchanged during the study period; 34. During screening, the blood amylase or lipase level should be greater than 1.5× ULN; 35. During screening, the 12-lead electrocardiogram shows a heart rate of <50 beats per minute or >100 beats per minute (a retest is allowed after 10 minutes, and the retest value shall prevail); 36. During screening, the following clinically significant abnormalities in 12-lead electrocardiograms (ECGs) are considered: second-degree or third-degree atrioventricular block, long QT syndrome or QTcF >450ms, PR interval <120ms or PR interval >220ms, QRS >120ms, left or right bundle branch block, pre-excitation syndrome, or other severe arrhythmias requiring treatment; 37. History of other risk factors for Torsade de Pointes (TdP) ventricular tachycardia, such as hypokalemia at screening, family history of Long QT Syndrome, or concurrent medication use that prolongs the QT/QTc interval at screening; 38. Individuals who have donated blood and/or lost blood volume ≥400mL within the previous 3 months, or have undergone bone marrow donation, or suffer from anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, or have a hemoglobin level <110g/L (male) or <100g/L (female) before screening; 39. During screening, if any of the following conditions exist:

    a. Use of strong or moderate CYP3A4 inhibitors or inducers within 28 days before screening, including but not limited to rifampin, rifapentine, carbamazepine, phenytoin, phenobarbital, St. John's wort, itraconazole, ketoconazole, voriconazole, ritonavir, cobistat, clarithromycin, etc; b. Those who are currently using simvastatin during screening and cannot discontinue it and switch to an alternative treatment regimen approved by the investigator; for those who have previously used simvastatin, they should discontinue it before screening and switch to an alternative treatment regimen approved by the investigator, and the alternative treatment regimen must be stable for at least 30 days before enrollment.

    40. Researchers believe that trial participants who possess any other factors that may affect the efficacy or safety evaluation of this study are not suitable to participate in this study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: TQF3250 capsules
This study established six treatment dose groups. Each group adopted a dose titration scheme, with trial participants titrating from a low dose to the target dose. Trial participants take TQF3250 capsules orally once daily for a total treatment period of 12 weeks.
Droga: TQF3250 capsules
An oral glucagon-like peptide-1 receptor agonist
Comparador de placebos: TQF3250 Placebo
The trial participants take TQF3250 placebo orally once daily, with a total treatment duration of 12 weeks.
Droga: TQF3250 placebo
Placebo contains no active substance.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Abnormal clinical examination findings
Periodo de tiempo: Baseline up to 14 weeks
Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram,etc.
Baseline up to 14 weeks
Adverse Event
Periodo de tiempo: Baseline up to 14 weeks
Incidence and Severity of All Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)
Baseline up to 14 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area Under the Curve from 0 to 24 hours(AUC0-24h)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
AUC0-24h following the first administration at target dose, and AUC0-24h after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Area Under the Curve from time zero to infinity(AUC0-∞)
Periodo de tiempo: pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6hours post-dose Days 36,50,64,78; pre-1st dose & 1,2,4,6,8,12,24hours post target dose; pre-dose & 1,2,4,6,8,12,24hours post Days 35,42; pre-dose & 1,2,4,6,8,12,24,48,96hours post Day 84.
AUC0-∞ following the first administration at target dose, and AUC0-∞ after multiple administrations
pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6hours post-dose Days 36,50,64,78; pre-1st dose & 1,2,4,6,8,12,24hours post target dose; pre-dose & 1,2,4,6,8,12,24hours post Days 35,42; pre-dose & 1,2,4,6,8,12,24,48,96hours post Day 84.
Area Under the Curve from time zero to the last quantifiable time point(AUC0-t)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
AUC0-t after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Maximum Plasma Concentration(Cmax)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Cmax following the first administration at target dose
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Minimum Steady-State Concentration(Css-min)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Css-min after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Maximum Steady-State Concentration(Css-max)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Css-max after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Average Steady-State Concentration(Css-avg)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Css-avg after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Elimination Half-Life(t1/2)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
t1/2 following the first administration at target dose and t1/2 after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Time to Maximum Concentration(Tmax)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Tmax after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Apparent Oral Clearance (CL/F)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
CL/F following the first administration at target dose and CL/F after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Apparent Volume of Distribution during Elimination Phase(Vz/F)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Vz/F following the first administration at target dose
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Apparent Volume of Distribution at Steady State(Vss/F)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Vss/F after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Terminal elimination rate constant(λz)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
λz following the first administration at target dose and λz after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Accumulation Ratio (Rac)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Rac after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Dose Fluctuation(DF)
Periodo de tiempo: Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
DF after multiple administrations
Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84.
Body Weight
Periodo de tiempo: Baseline up to 12 weeks
Percentage change in body weight compared to baseline, as well as the proportion of trial participants whose body weight decreased by ≥5%, ≥10%, and ≥15% compared to baseline
Baseline up to 12 weeks
Body Mass Index (BMI)
Periodo de tiempo: Baseline up to 12 weeks
Change in BMI compared to baseline
Baseline up to 12 weeks
Waist Circumference
Periodo de tiempo: Baseline up to 12 weeks
Change from baseline in waist circumference
Baseline up to 12 weeks
Hip circumference
Periodo de tiempo: Baseline up to 12 weeks
Change from baseline in hip circumference
Baseline up to 12 weeks
waist-to-hip ratio
Periodo de tiempo: Baseline up to 12 weeks
Change from baseline in waist-to-hip ratio
Baseline up to 12 weeks
Glycated hemoglobin (HbA1c)
Periodo de tiempo: Baseline up to 12 weeks
Change from baseline in HbA1c
Baseline up to 12 weeks
Fasting Plasma Glucose (FPG)
Periodo de tiempo: Baseline up to 12 weeks
Change from baseline in FPG
Baseline up to 12 weeks
C-peptide
Periodo de tiempo: Baseline up to 12 weeks
Change in C-peptide compared to baseline
Baseline up to 12 weeks
Insulin
Periodo de tiempo: Baseline up to 12 weeks
Change in Insulin compared to baseline
Baseline up to 12 weeks
blood pressure
Periodo de tiempo: Baseline up to 12 weeks
Changes in systolic and diastolic blood pressure compared to baseline
Baseline up to 12 weeks
blood lipids
Periodo de tiempo: Baseline up to 12 weeks
Changes in blood lipids compared to baseline
Baseline up to 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

27 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de agosto de 2026

Publicado por primera vez (Actual)

1 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TQF3250-Ib-02

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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