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New 'Smarter' GLP-1 drug enters first human tests for blood sugar control

NCT ID NCT07327281

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called TQF3250 in 66 healthy adults with high blood sugar. The drug is designed to activate only certain parts of the GLP-1 receptor, aiming for better blood sugar control with fewer side effects. The main goal is to check safety and how the body handles the drug, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TQF3250 capsule (biased GLP-1 receptor agonist)
What this could lead to
If successful, this could lead to a new treatment option for high blood sugar with fewer side effects than current GLP-1 drugs.
What could go wrong
This is a very early Phase 1 trial in only 66 healthy people, so it is too soon to know if it works or is safe. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Chinese subjects aged above 18 years old (including 18 years old) and below 55 years old (including 55 years old); * Those who voluntarily sign a written informed consent form before the trial, have a full understanding of the trial content, process and possible adverse reactions, can communicate well with the researcher, and understand and comply with the requirements of this study; * Women of childbearing potential should agree to use effective contraceptive measures during the study and for 6 months after the end of the study; * Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 20-40kg/m2 (including both ends of the cutoff); Exclusion Criteria: * Pregnant and lactating women. * Those whose vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, anteroposterior chest X-ray, and abdominal ultrasound results during the screening period are abnormal and have clinical significance. * Those who have had or currently have diseases/abnormalities such as heart, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, blood, nerve or mental illness, or related chronic diseases, or acute diseases, and the researcher assesses that they are not suitable to participate in the trial: * Have active tuberculosis during the screening period, or be a close household contact of an untreated active tuberculosis patient. * Have a history of severe bacterial, fungal or viral infection within 2 months before randomization, requiring hospitalization with intravenous antibiotics or antiviral drug treatment; * Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures; * Subjects with any bleeding or bleeding events ≥ Common Terminology Criteria (CTC) AE grade 3 within 4 weeks before the first dose; * Clinically significant infections occur during the screening period, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, and require antibiotic or antiviral drug treatment. * Have a history of severe herpes zoster or herpes simplex infection, including but not limited to herpetic encephalitis, disseminated herpes simplex, and generalized herpes zoster. * Use any systemic cytotoxic or systemic immunosuppressive drugs within 6 months before randomization or within the study period, or use any local cytotoxic or local immunosuppressive drugs within 4 weeks before randomization or within 5 half-lives (whichever is longer) or during the study period. * Have received any other biological agents on the market or under investigation within 3 months or 5 half-lives (whichever is longer) before randomization. * Have received a live vaccine within 4 weeks before randomization or plan to receive a live vaccine during the study. * Those who have undergone surgery within 4 weeks before randomization, or plan to have surgery during the study period. * Those who lost blood or donated more than 400 mL of blood within 4 weeks before randomization. * Taking any prescription drugs, non-prescription drugs and herbal medicines within 4 weeks before randomization, except vitamin products. * Those who have difficulty collecting blood and have a history of fainting from needles or bleeding. * Are allergic to any known ingredients of TQF3250 capsules, or have any history of severe drug allergy. * Those with a history of drug abuse or positive urine drug screening. * Those who smoke more than 5 cigarettes/day or use a considerable amount of nicotine or nicotine-containing products within 3 months before randomization, or who cannot stop using any tobacco products during the trial. * Those who have been alcoholics for a long time or who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) within 3 months before screening, or who cannot abstain from alcohol during the test, or who have a positive alcohol breath test. * Those who habitually consume too many caffeinated drinks or foods within 4 weeks before screening. Have consumed grapefruit, bitter orange and the juice of these fruits within 7 days before the first dose, or cannot stop consuming grapefruit, bitter orange and the juice of these fruits during the study; * Those who have special dietary requirements and cannot accept standard diet; * There are any other reasonable medical, mental or social reasons that the researcher believes to be unable to participate in this study. * Those who are unable to comply with the trial plan; * Those who participated in and used other clinical trial drugs within three months before the first medication;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Drum Tower Hospital Affiliated to Nanjing University School of Medicine

    RECRUITING

    Nanjing, Jiangsu, 210008, China

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