Obesity & OverweightPhase 3NCT07648225
UBT251 Injection Phase Ⅲ Study (Overweight or Obesity)
A Phase 3 study testing UBT251 Injection 4.0 mg and UBT251 Injection 6.0 mg in people with Obesity & Overweight, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
Trial summary
This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- UBT251 Injection 4.0 mg and UBT251 Injection 6.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 3 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender;
- 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;
- 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;
- 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;
- Have been fully informed about this study and voluntarily sign a written informed consent form.
Who cannot join
- Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
- Any of the following medication history within 3 months before randomization:
- 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;
- 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);
- 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);
- Treatment with tricyclic antidepressants, antipsychotics, or antiepileptic medications;
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- Treatment with antidiabetic medications;
- History or evidence of any of the following diseases:
- Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (excluding history of gestational diabetes mellitus);
- 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.);
- History of acute or chronic pancreatitis, or pancreatic surgery;
- 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;
- 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);
- 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;
- History of depression or severe mental illness (including but not limited to suicidal tendencies, schizophrenia, bipolar disorder, etc.);
- History of clinically significant cardiovascular or cerebrovascular disease within 6 months before screening;
- 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;
- History of malignancy;
- Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion;
- Lactating women or pregnant women;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing
Weinong Ji, 13910978815, jiln@bjmu.edu.cn
About this study
Official title: A PhaseⅢ Study to Evaluate the Efficacy and Safety of UBT251 Injection in Overweight/Obese Patients
This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
- Conditions
- Obesity & Overweight
- Being tested
- UBT251 Injection 4.0 mg, UBT251 Injection 6.0 mg, UBT251 Injection Placebo 4.0 mg, UBT251 Injection Placebo 6.0 mg
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT251 Injection 4.0 mgDrug
UBT251 Injection subcutaneously once weekly
UBT251 Injection 6.0 mgDrug
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection Placebo 4.0 mgDrug
UBT251 Injection placebo subcutaneously once weekly
UBT251 Injection Placebo 6.0 mgDrug
UBT251 Injection placebo subcutaneously once weekly
| Study group | Role | What they receive |
|---|---|---|
| UBT251 Injection 4.0 mg | Experimental | Each subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection 4.0 mg |
| UBT251 Injection 6.0 mg | Experimental | Each subject will receive UBT251 Injection, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection 6.0 mg |
| UBT251 Injection Placebo 4.0 mg | Placebo comparator | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection Placebo 4.0 mg |
| UBT251 Injection Placebo 6.0 mg | Placebo comparator | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. Receives: Drug: UBT251 Injection Placebo 6.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Percentage change in body weight from baseline after 52 weeks of treatment
Measured: Week 52
Secondary outcomes (8)
Waist Circumference
Changes from baseline in waist circumference at each visit
Measured: Through study completion, an average of one year
BMI
Changes from baseline in BMI at each visit
Measured: Through study completion, an average of one year
Systolic blood pressure
Changes from baseline in systolic blood pressure at each visit
Measured: Through study completion, an average of one year
Diastolic blood pressure
Changes from baseline in diastolic blood pressure at each visit
Measured: Through study completion, an average of one year
HbA1c
change in HbA1c from baseline after 12 weeks 、24 weeks 、32 week、52 weeks of treatment
Measured: Week 12 、Week 24、Week 32、Week 52
Fasting Serum Lipids
change in fasting serum lipids from baseline after 12 weeks 、24 weeks 、32 week、52 weeks of treatment
Measured: Week 12 、Week 24、Week 32、Week 52
SF-36 v2 scores
Changes from baseline in SF-36 v2 scores at Weeks 12, 24, 32, and 52
Measured: Week 12 、Week 24、Week 32、Week 52
Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores
Changes from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores at Weeks 12, 24, 32, and 52
Measured: Week 12 、Week 24、Week 32、Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start31 Jul 2026 (estimated)
- Primary completion29 Sep 2027 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by The United Bio-Technology (Hengqin) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648225
- Sponsor's protocol ID
- TUL-UBT251（III-1）202601
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅢ Study to Evaluate the Efficacy and Safety of UBT251 Injection in Overweight/Obese Patients
- ClinicalTrials.gov ID
- NCT07648225
- Acronym / sponsor ID
- TUL-UBT251（III-1）202601
- Conditions
- Obesity & Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UBT251 Injection 4.0 mg | Experimental | Drug: UBT251 Injection 4.0 mgEach subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection 6.0 mg | Experimental | Drug: UBT251 Injection 6.0 mgEach subject will receive UBT251 Injection, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection Placebo 4.0 mg | Placebo comparator | Drug: UBT251 Injection Placebo 4.0 mgEach subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection Placebo 6.0 mg | Placebo comparator | Drug: UBT251 Injection Placebo 6.0 mgEach subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender;
- 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;
- 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;
- 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;
- Have been fully informed about this study and voluntarily sign a written informed consent form.
Key exclusion criteria (20 listed)
- Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
- Any of the following medication history within 3 months before randomization:
- History or evidence of any of the following diseases:
- Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion;
- Lactating women or pregnant women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBT251 Injection 4.0 mgUBT251 Injection subcutaneously once weekly | Drug | UBT251 Injection 4.0 mg |
| UBT251 Injection 6.0 mgUBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly | Drug | UBT251 Injection 6.0 mg |
| UBT251 Injection Placebo 4.0 mgUBT251 Injection placebo subcutaneously once weekly | Drug | UBT251 Injection Placebo 4.0 mg |
| UBT251 Injection Placebo 6.0 mgUBT251 Injection placebo subcutaneously once weekly | Drug | UBT251 Injection Placebo 6.0 mg |
Primary outcome
Body Weight
Time frame: Week 52
Percentage change in body weight from baseline after 52 weeks of treatment
8 secondary outcomes
Waist Circumference
Time frame: Through study completion, an average of one year
BMI
Time frame: Through study completion, an average of one year
Systolic blood pressure
Time frame: Through study completion, an average of one year
Diastolic blood pressure
Time frame: Through study completion, an average of one year
HbA1c
Time frame: Week 12 、Week 24、Week 32、Week 52
Fasting Serum Lipids
Time frame: Week 12 、Week 24、Week 32、Week 52
SF-36 v2 scores
Time frame: Week 12 、Week 24、Week 32、Week 52
Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores
Time frame: Week 12 、Week 24、Week 32、Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UBT251 Injection 4.0 mg and UBT251 Injection 6.0 mg in people with Obesity & Overweight, run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weilong Tao (13770691686, taowl@tul.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.