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

NCT07798284 | Not Yet Recruiting Phase 1

• 1 other identifier: TQF3250-Ib-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Overweight/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 (26)

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

  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-∞)

  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)

  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)

  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)

  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.

Study Arms (2)

TQF3250 capsules

EXPERIMENTAL

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.

Drug: TQF3250 capsules

TQF3250 Placebo

PLACEBO COMPARATOR

The trial participants take TQF3250 placebo orally once daily, with a total treatment duration of 12 weeks.

Drug: TQF3250 placebo

Interventions

TQF3250 capsules DRUG

An oral glucagon-like peptide-1 receptor agonist

TQF3250 capsules

TQF3250 placebo DRUG

Placebo contains no active substance.

TQF3250 Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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;
• Participants who have participated in other clinical trials (and have received trial drug treatment) within the previous 3 months;
• Patients with previously diagnosed diabetes (including type 1 or type 2 diabetes, etc.);
• Screen for patients with fasting venous blood glucose levels ≥7.0 mmol/L or glycated hemoglobin levels ≥6.5%;
• Participants who have experienced unexplained hypoglycemic events (blood glucose \<3.9 mmol/L) within the previous 1 month before screening;
• 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);
• 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);
• 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);
• Previous history of depression; suicidal tendencies or suicide attempts, or previous history of severe mental illnesses, such as schizophrenia, bipolar disorder, etc;
• 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;
• Having any malignant tumor within the past 5 years (excluding basal cell carcinoma that has undergone curative treatment and is considered cured);

Sponsors & Collaborators

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

Study Sites (10)

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

Zhengzhou People's Hospital

Zhengzhou, Henan, 450003, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

Xianning Central Hospital

Xianning, Hubei, 437100, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250013, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

The First People's Hospital of Xiaoshan Hangzhou

Hangzhou, Zhejiang, 311201, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Linong Ji, Doctor

CONTACT

13910978815; jiln@bjmu.edu.cn

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: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CN (10)