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New weekly shot could help control diabetes and weight

NCT ID NCT07659574

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a new injection called UBT251 in 360 adults with type 2 diabetes who have not been able to control their blood sugar with diet and exercise alone. Participants will receive either a weekly shot of UBT251 (at different doses) or a placebo for several weeks. The main goal is to see if the drug lowers blood sugar levels (HbA1c) and helps with weight loss.

What this could mean

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

Active substance
UBT251 injection (a weekly shot to help control blood sugar and weight)
What this could lead to
If successful, this could offer a new weekly injection option for people with type 2 diabetes to better manage blood sugar and possibly lose weight.
What could go wrong
This is a Phase 3 trial, so it's still being tested. The drug may not work better than placebo, and side effects (like nausea or other gastrointestinal issues) are possible. Results may not apply to everyone with diabetes.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

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

Started

Sep 2026

Expected to finish

Oct 2027

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 75 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: 1. Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender; 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria; 3. Managed solely through diet and exercise intervention (without the use of any glucose-lowering medications) for at least 3 months prior to screening; 4. Glycated hemoglobin (HbA1c) level ≥7.5% and ≤10.5% at screening; 5. Body mass index (BMI) ≥23.0 kg/m² at screening, and stable body weight (change \<5%, which may be based on the participant's self-report) within 3 months prior to screening; 6. Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion; 7. Have been fully informed about this study and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs; 2. History of medication use within 3 months prior to screening that meets any of the following conditions: 1\) Use of any glucose-lowering medications, including glucagon-like peptide-1 (GLP-1) analogues, oral antidiabetic drugs (OADs) (including but not limited to metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, glinides, sodium-glucose cotransporter 2 (SGLT-2) inhibitors), insulin (except for short-term use ≤14 days for acute conditions, such as perioperative or inpatient use), traditional Chinese medicines, or health supplements with glucose-lowering effects; 2) Use of medications that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc. (except for cumulative use \<7 days with the last dose administered more than 7 half-lives prior to the first day of screening); 3) Use of weight-loss medications (including but not limited to orlistat, liraglutide, or other similar prescription or over-the-counter medications for weight loss); 3.History or evidence of any of the following diseases: 1. Diagnosis of other types of diabetes: such as type 1 diabetes mellitus (T1DM), other specific types of diabetes (e.g., genetic defects in beta-cell function, genetic defects in insulin action, diseases of the exocrine pancreas, etc.); 2. History of acute or chronic pancreatitis, or pancreatic surgery; 3. History of symptomatic gallbladder disease within 1 year before screening (excluding trial participants who have undergone cholecystectomy \[completed at least 3 months before screening\] without long-term complications), or abdominal ultrasound at screening indicating large gallstones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the study physician determines may affect trial participant safety; 4. Personal or family history (within first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); 5. History of hematological disorders that may affect HbA1c test results or increase the risk to trial participants (e.g., aplastic anemia, myelodysplastic syndromes, etc.), or any diseases causing hemolysis or erythrocyte instability (e.g., sickle cell disease, thalassemia, etc.); 6. History of moderate to severe depression or severe psychiatric disorders (including but not limited to suicidal ideation or attempt, schizophrenia, bipolar disorder, etc.); 7. History of clinically significant cardiovascular or cerebrovascular disease within 6 months before screening 8. Severe retinal or macular disease (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) at screening or in the past, requiring urgent treatment as determined by the study physician; 9. Severe hypoglycemia (hypoglycemia accompanied by severe cognitive impairment requiring assistance from others to recover) or recurrent symptomatic hypoglycemia (≥2 episodes in 6 months) within 6 months prior to screening; 10. History of acute metabolic complications of diabetes (including but not limited to diabetic ketoacidosis \[DKA\], hyperosmolar hyperglycemic state \[HHS\] requiring hospitalization, hyperosmolar coma, lactic acidosis, etc.) or diabetic foot within 6 months prior to screening; 11. History of malignancy; 4.Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion; 5.Lactating women or pregnant women;

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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

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

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Other studies related to the condition(s) this trial covers.