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Weekly shot could help shed pounds in obesity trial

NCT ID NCT07648225

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 study tests whether a weekly injection called UBT251 can help overweight or obese adults lose weight. Participants receive either the drug or a placebo for 52 weeks. The main goal is to measure the percentage change in body weight, with additional checks on waist size, BMI, and blood pressure. The trial includes adults aged 18-75 with a BMI of 24 or higher who also have conditions like prediabetes, high blood pressure, or fatty liver.

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
What this could lead to
If successful, this could offer a new weekly injection option for significant weight loss in people with obesity or overweight who have related health issues.
What could go wrong
This is a phase 3 trial, but results may not apply to everyone. Side effects are possible, and the drug may not work as well in real-world settings or for all participants.

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 600 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 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. Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender; 2. Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI \<28.0 kg/m² (overweight) at screening, accompanied by by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome; 3. Self-reported having been on diet and exercise control for 3 months or more prior to screening, with body weight change ≤5 kg within the past 3 months; 4. 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; 5. 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. Any of the following medication history within 3 months before randomization: 1. Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, glucagon-like peptide-1 (GLP-1) analogs, glucose-dependent insulinotropic polypeptide (GIP) analogs, or glucagon (GCG) analogs; 2. Use of over-the-counter weight-loss medications or appetite suppressants (including traditional Chinese medicine, dietary supplements, meal replacements), or prescription weight-loss medications (including but not limited to orlistat) or lipolytic injections (e.g., fat-dissolving injections); 3. Use of medications that may affect body weight for a duration of 1 week or longer, or anticipated use during the trial, including but not limited to systemic glucocorticoid therapy (intravenous or oral administration, except for the following: topical external use or intra-articular, intranasal, ophthalmic, and inhaled glucocorticoids; short-term \[≤7 days\] systemic glucocorticoid use for prevention or treatment of non-autoimmune allergic diseases, upper respiratory tract infection); 4. Treatment with tricyclic antidepressants, antipsychotics, or antiepileptic medications; 5. Treatment with antidiabetic medications; 3. History or evidence of any of the following diseases: 1. Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (excluding history of gestational diabetes mellitus); 2. Secondary obesity caused by diseases (including but not limited to elevated cortisol hormones \[e.g., Cushing's syndrome\], pituitary/hypothalamic injury, hypothyroidism, etc.) or medications (including but not limited to long-term glucocorticoid use, antidepressants, etc.); 3. History of acute or chronic pancreatitis, or pancreatic surgery; 4. 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; 5. 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); 6. Planned bariatric surgery during the trial or history of bariatric surgery, except for the following: a) acupuncture for weight loss or liposuction (e.g., abdominal liposuction) performed \>1 year before screening; b) gastric banding, but the band was removed \>1 year before screening; c) intragastric balloon, but the balloon was removed \>1 year before screening; d) duodenal-jejunal bypass liner, but the liner was removed \>1 year before screening; 7. History of depression or severe mental illness (including but not limited to suicidal tendencies, schizophrenia, bipolar disorder, etc.); 8. History of clinically significant cardiovascular or cerebrovascular disease within 6 months before screening; 9. 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; 10. 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.

Obesity obesity disorder Overweight

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

  • Peking University People's Hospital

    Beijing, China

More trials for these conditions

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