A Clinical Trial Evaluating TQF3250 Capsules in Patients With Type 2 Diabetes Mellitus and Overweight/Obesity

NCT07747857 | Recruiting Phase 1

• 1 other identifier: TQF3250-Ib-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus Combined With Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  Incidence and Severity of All Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs).

  Baseline up to 14 weeks

• Abnormal clinical examination findings

  Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram,etc.

  Baseline up to 14 weeks

Secondary Outcomes (23)

• Area Under the Curve from 0 to 24 hours(AUC0-24h)

  Prior to dose on Day 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose on Day 36,50,64,78. At target dose: Prior to 1st dose and 1,2,4,6,8,12,24 hours after. Prior to last dose and 1,2,4,6,8,12,24,48,96 hours after.

• Area Under the Curve from time zero to infinity(AUC0-∞)

  Prior to dose on Day 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose on Day 36,50,64,78. At target dose: Prior to 1st dose and 1,2,4,6,8,12,24 hours after. Prior to last dose and 1,2,4,6,8,12,24,48,96 hours after.

• Area Under the Curve from time zero to the last quantifiable time point(AUC0-t)

  Prior to dose on Day 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose on Day 36,50,64,78. At target dose: Prior to 1st dose and 1,2,4,6,8,12,24 hours after. Prior to last dose and 1,2,4,6,8,12,24,48,96 hours after.

• Maximum Plasma Concentration(Cmax)

  Prior to dose on Day 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose on Day 36,50,64,78. At target dose: Prior to 1st dose and 1,2,4,6,8,12,24 hours after. Prior to last dose and 1,2,4,6,8,12,24,48,96 hours after.

• Minimum Steady-State Concentration(Css-min)

  Prior to dose on Day 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose on Day 36,50,64,78. At target dose: Prior to 1st dose and 1,2,4,6,8,12,24 hours after. Prior to last dose and 1,2,4,6,8,12,24,48,96 hours after.

Study Arms (2)

TQF3250 capsules

EXPERIMENTAL

Six treatment dose groups (4 mg, 8 mg, 12 mg, 24 mg, 32 mg and 40 mg) are established in this study. A dose titration regimen is adopted for each group, where subjects are titrated from low doses to the target dose. Trial subjects will receive oral administration of TQF3250 capsules once daily (QD) under fasting conditions for a total treatment period of 12 weeks.

Drug: TQF3250 capsules

TQF3250 Placebo

PLACEBO COMPARATOR

Trial subjects will receive oral administration of TQF3250 placebo once daily (QD) under fasting conditions for a total treatment period of 12 weeks.

Drug: TQF3250 placebo

Interventions

TQF3250 capsules DRUG

An oral glucagon-like peptide-1 receptor agonist.

TQF3250 capsules

TQF3250 placebo DRUG

TQF3250-matched placebo capsules.

TQF3250 Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years, inclusive.
• 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.
• Diagnosed with type 2 diabetes mellitus combined with overweight or obesity at screening, in accordance with the 1999 WHO diagnostic criteria.
• 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.

You may not qualify if:

• 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;
• Presence of proliferative retinopathy or macular lesions requiring acute treatment, painful diabetic neuropathy, diabetic foot or intermittent claudication confirmed by ophthalmic examination or medical records within 90 days prior to randomization;
• Presence of diseases judged by the investigator to be clinically significant and likely to compromise subject safety, interfere with study drug metabolism, or confound evaluation of study outcomes, including but not limited to diseases of the nervous, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, hematological and immune systems (excluding complications related to type 2 diabetes mellitus).
• Other medical conditions and medical history
• Any condition that may interfere with drug absorption;
• Concurrent hyperthyroidism, Cushing's syndrome, diabetic gastroparesis or other diseases associated with gastric emptying disorders, gastrointestinal diseases assessed by the investigator to increase postdosing risks, anorexia nervosa, alcohol dependence, drug abuse, substance dependence, epilepsy, psychiatric disorders, or conditions requiring systemic antiinfective treatment. Subjects with subclinical hypothyroidism or well-controlled hypothyroidism under stable medication are eligible for enrollment;
• Medical history of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association (NYHA) Class II-IV heart failure, or transient ischemic attack within 6 months prior to screening; or medical history of clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic medication;
• Clinically significant abnormal electrocardiogram (ECG) results at screening or randomization, such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second or third-degree atrioventricular block, and deemed unsuitable for study participation by the investigator;
• Resting blood pressure: systolic blood pressure (SBP) ≥160 mmHg or \<90 mmHg, and/or diastolic blood pressure (DBP) ≥100 mmHg; or initiation, modification or dose adjustment of antihypertensive drugs within 4 weeks prior to screening;
• Any major surgery performed within 30 days prior to the first dose of study treatment, or any surgery planned during the study period;
• Current malignancy or medical history of cancer or lymphoproliferative disease within the past 5 years (except fully treated basal cell carcinoma or squamous cell carcinoma of the skin with no evidence of recurrence);
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or subjects suspected of MTC per investigator judgment;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (12)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Hebei Petro China Central Hosptial

Langfang, Hebei, 065000, China

NOT YET RECRUITING

Luoyang First People's Hospital

Luoyang, Henan, 471000, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, 443003, China

NOT YET RECRUITING

The Third Hospital of Changsha

Changsha, Hunan, 410015, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250013, China

NOT YET RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

NOT YET RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646099, China

NOT YET RECRUITING

The First People's Hospital of Xiaoshan Hangzhou

Hangzhou, Zhejiang, 311201, China

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dalong Zhu, Doctor

CONTACT

13805150781; zhudalong@nju.edu.cn

Juan Li, Doctor

CONTACT

15951989771; Juanli2003@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CN (12)