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

27. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking University People's Hospital
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Kontakt:
        • Kontakt:
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou First People's Hospital
        • Kontakt:
          • Suiqin Ni, Master
          • Telefonnummer: 18933962556
          • E-Mail: n_sql@126.com
        • Kontakt:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Zhengzhou People's Hospital
        • Kontakt:
          • Yong Last Name 姓 Tian 田, Master
          • Telefonnummer: 13673686680
          • E-Mail: 47679410@qq.com
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
        • Kontakt:
      • Xianning, Hubei, China, 437100
        • Xianning Central Hospital
        • Kontakt:
    • Shandong
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
        • Kontakt:
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200072
        • Shanghai Tenth People's Hospital
        • Kontakt:
        • Kontakt:
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital of Southwest Medical University
        • Kontakt:
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311201
        • The First People's Hospital of Xiaoshan Hangzhou
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: TQF3250 capsules
An oral glucagon-like peptide-1 receptor agonist
Placebo-Komparator: TQF3250 Placebo
The trial participants take TQF3250 placebo orally once daily, with a total treatment duration of 12 weeks.
Arzneimittel: TQF3250 placebo
Placebo contains no active substance.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Abnormal clinical examination findings
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Area Under the Curve from 0 to 24 hours(AUC0-24h)
Zeitfenster: 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-∞)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Baseline up to 12 weeks
Change in BMI compared to baseline
Baseline up to 12 weeks
Waist Circumference
Zeitfenster: Baseline up to 12 weeks
Change from baseline in waist circumference
Baseline up to 12 weeks
Hip circumference
Zeitfenster: Baseline up to 12 weeks
Change from baseline in hip circumference
Baseline up to 12 weeks
waist-to-hip ratio
Zeitfenster: Baseline up to 12 weeks
Change from baseline in waist-to-hip ratio
Baseline up to 12 weeks
Glycated hemoglobin (HbA1c)
Zeitfenster: Baseline up to 12 weeks
Change from baseline in HbA1c
Baseline up to 12 weeks
Fasting Plasma Glucose (FPG)
Zeitfenster: Baseline up to 12 weeks
Change from baseline in FPG
Baseline up to 12 weeks
C-peptide
Zeitfenster: Baseline up to 12 weeks
Change in C-peptide compared to baseline
Baseline up to 12 weeks
Insulin
Zeitfenster: Baseline up to 12 weeks
Change in Insulin compared to baseline
Baseline up to 12 weeks
blood pressure
Zeitfenster: Baseline up to 12 weeks
Changes in systolic and diastolic blood pressure compared to baseline
Baseline up to 12 weeks
blood lipids
Zeitfenster: Baseline up to 12 weeks
Changes in blood lipids compared to baseline
Baseline up to 12 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

27. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. August 2026

Zuerst gepostet (Tatsächlich)

1. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TQF3250-Ib-02

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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