Overweight , ObesityPhase 1NCT07873645
Study of UBT37034 Injection
A Phase 1 study testing UBT37034 in people with Overweight , Obesity, run by The United Bio-Technology (Hengqin) Co., Ltd..
Trial summary
This is a study of UBT37034 for injection in participants who have obesity or are overweight. The main purpose is to learn more about the safety, tolerability, drug concentration, drug action and immune response of repeated UBT37034 administration. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- UBT37034
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2027
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-55 years (inclusive) at the time of informed consent form (ICF) signing;
- BMI ≥24 kg/m² at screening; weight >60 kg (male) or >50 kg (female) at screening;
- Self-reported ≥3 months of diet and exercise control before screening, with ≤5% weight change in the prior 3 months;
- The participant (and partner) has no plan for pregnancy from screening until 6 months after study completion. The participant is willing to use study-specified contraception. No sperm or egg donation is permitted within 6 months after study completion;
- Fully understands the study and provides voluntary written informed consent.
Who cannot join
- Suspected or confirmed hypersensitivity to components of products similar to the investigational product, or to any excipient of the investigational product; or subjects with allergic diathesis (multiple drug and food allergies).
- History of medication meeting any of the following criteria:
- 1）Use of prescription drugs, over-the-counter drugs, vitamin products, or herbal medicines within 14 days prior to screening or within at least 5 half-lives (whichever is longer); stable fixed-dose antihypertensive or lipid-lowering medications that have been taken for at least 1 month and have no impact on glucose metabolism and body weight are permitted； 2) received vaccination within 1 month before screening or planned to receive vaccination during the study; 3) used weight-modifying medications within 3 months before screening, including but not limited to marketed or investigational anti-obesity agents (e.g., GLP-1 analogues, orlistat), agents with mechanism similar to neuropeptide Y receptor agonists, tricyclic antidepressants, psychotropic agents or sedatives (e.g., mirtazapine, paroxetine, olanzapine, valproic acid and its derivatives); 4) used antihyperglycemic drugs within 3 months before screening (including but not limited to metformin, SGLT2 inhibitors, thiazolidinediones [TZDs], etc.) or agents that may alter glucose metabolism (e.g., systemic glucocorticoids, growth hormone).
- History or evidence of any of the following conditions:
- Presence of clinically severe disease or clinically significant abnormality within 1 year prior to screening (including but not limited to disorders of the neuropsychiatric, cardiovascular, respiratory, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, skeletal systems, etc.), which, in the opinion of the investigator, may compromise the safety of the trial participant, assessment of efficacy, or subject compliance;
- Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (history of gestational diabetes mellitus excluded);
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- Secondary obesity caused by diseases (including but not limited to elevated cortisol [e.g., Cushing syndrome], pituitary/hypothalamic injury, hypothyroidism, etc.) or medications (including but not limited to long-term glucocorticoid use, antidepressants, etc.);
- History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening, defined as:
- Myocardial infarction (MI) or unstable angina;
- Cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention);
- Congestive heart failure (New York Heart Association (NYHA) Class III-IV);
- Cerebrovascular accident (old lacunar infarction excluded), including but not limited to hemorrhagic or ischemic stroke, or transient ischemic attack;
- Other cardiovascular and cerebrovascular diseases deemed unsuitable for participation in this trial as assessed by the investigator;
- Prior or current severe retinal or macular disease at screening (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) that requires urgent further treatment as judged by the investigator;
- History of severe hypoglycemia (hypoglycemia accompanied by severe cognitive impairment requiring other therapeutic interventions for recovery) or recurrent symptomatic hypoglycemia (≥2 episodes within 6 months);
- Gastrointestinal emptying disorders at screening (e.g., gastroparesis, pyloric obstruction, intestinal obstruction, etc.), gastrointestinal diseases assessed by the investigator to increase risks after study drug administration (e.g., severe active ulcer, inflammatory bowel disease, acute gastroenteritis, uncontrolled gastroesophageal reflux disease, etc.), or a history of major gastrointestinal surgery (excluding fully recovered procedures such as gastrointestinal polypectomy, appendectomy, cholecystectomy, etc., which are judged by the investigator not to affect trial safety);
- Prior history of depression, or a Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening, or history of severe psychiatric disorders (including but not limited to suicidal ideation, schizophrenia, bipolar disorder, etc.);
- Positive response to suicidal ideation Item 4 or Item 5, or any positive response to suicidal behavior-related questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening;
- Major surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for this study by the investigator;
- Prior history of malignant neoplasm;12) Limb deformity or disability that prevents accurate measurement of height, weight, or other indicators.
- Abnormal laboratory findings at screening meeting any of the following:
- Glycated hemoglobin (HbA1c) ≥6.5% or fasting venous glucose ≥7.0 mmol/L. If the participant's fasting glucose during screening is 6.1-6.9 mmol/L, an oral glucose tolerance test (OGTT) is required for confirmation; subjects with a 2-hour post-load glucose ≥11.1 mmol/L will be excluded;
- Hepatic or renal impairment: serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2 × upper limit of normal (ULN); serum total bilirubin ≥1.5 × ULN; estimated glomerular filtration rate (eGFR) <90 mL·min-¹·1.73m-² (calculated using the CKD-EPI 2021 equation);
- Thyroid dysfunction that cannot be controlled with a stable drug dose (for ≥3 months), or clinically significant abnormalities in thyroid function tests at screening requiring initiation of treatment;
- Fasting triglycerides ≥5.6 mmol/L;
- Serum amylase and/or lipase >2.0 × ULN;
- International normalized ratio (INR) greater than the upper limit of normal;
- Hemoglobin <100 g/L;
- Systolic blood pressure ≥160 mmHg or <90 mmHg, or diastolic blood pressure ≥100 mmHg or <60 mmHg;
- Clinically significant electrocardiogram (ECG) abnormalities, such as:a) Second- or third-degree atrioventricular block;b) Long QT syndrome, or QT interval corrected using Fridericia's formula (QTcF) >450 ms;c) Wolff-Parkinson-White syndrome;d) Heart rate <50 beats per minute (bpm) or >100 beats per minute (bpm);e) Other severe arrhythmias requiring treatment;
- Positive hepatitis B surface antigen, positive hepatitis C virus antibody, positive human immunodeficiency virus antibody, or positive syphilis antibody at screening;
- Clinically significant abnormalities identified on physical examination, laboratory tests, etc., who, in the investigator's judgment, may pose substantial risk to the trial participant or interfere with the evaluation of safety and pharmacokinetics (PK) results, rendering them unsuitable for participation in this trial.
- Participation in other interventional clinical trials within 3 months prior to screening (excluding those who only completed screening without randomization/enrollment, or those enrolled but did not receive study treatment);
- Blood loss ≥400 mL (including trauma, blood sampling, blood donation) within 3 months prior to screening, or received transfusion of blood or blood components;
- History of substance abuse, or positive urine drug screening;
- Smoked more than 5 cigarettes or equivalent tobacco products per day within 3 months prior to screening, or unable to abstain from smoking during the trial;
- Female subjects consuming >7 standard drinks per week or male subjects consuming >14 standard drinks per week within 28 days prior to screening (1 standard drink = 150 mL wine = 360 mL beer = 45 mL spirits), or consumed any alcohol-containing products within 48 hours before dosing, or had a positive breath alcohol test at the baseline visit, or unable to abstain from alcohol during the trial;
- Consumed excessive amounts of tea, coffee or caffeine-containing beverages (>8 cups per day; 1 cup = 200 mL) within 14 days prior to screening, or consumed grapefruit, pomelo, or xanthine-rich foods/beverages; or unable to discontinue consumption of xanthine-rich foods or beverages (e.g., chocolate, tea, coffee, cola, etc.), grapefruit, pomelo, and products containing grapefruit or pomelo components (grapefruit juice, pomelo juice, etc.) from 48 hours prior to the first dose and throughout the trial period;
- Female subjects who are breastfeeding or pregnant;
- Intolerant to venipuncture, or with a history of vasovagal syncope triggered by needles or blood exposure;
- Unable to maintain regular diet and exercise during the trial, or other conditions deemed by the investigator to render the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Subcutaneous Administration of UBT37034 Injection in Overweight/Obesity Trial Participants
This is a study of UBT37034 for injection in participants who have obesity or are overweight. The main purpose is to learn more about the safety, tolerability, drug concentration, drug action and immune response of repeated UBT37034 administration. This is a single-center, randomized, double-blind, placebo-controlled study with multiple ascending doses. A total of 40 participants will be enrolled in 4 different dose groups. Participants will receive UBT37034 or placebo in an 8:2 random ratio with dose titration. The study will last up to 24 weeks and includes screening, treatment and safety follow-up periods.
- Conditions
- Overweight , Obesity
- Being tested
- UBT37034, Placebo
- Keywords
- Overweight, Obesity, UBT37034, safety, tolerability
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT37034Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| UBT37034 Dose 1 | Experimental | Participants will receive UBT37034 subcutaneously (SC). Receives: Drug: UBT37034 |
| UBT37034 Dose 2 | Experimental | Participants will receive UBT37034 subcutaneously (SC). Receives: Drug: UBT37034 |
| UBT37034 Dose 3 | Experimental | Participants will receive UBT37034 subcutaneously (SC). Receives: Drug: UBT37034 |
| UBT37034 Dose 4 | Experimental | Participants will receive UBT37034 subcutaneously (SC). Receives: Drug: UBT37034 |
| Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Baseline to Week23
Change from baseline in physical examinations
Measured: Baseline to Week 23
Change from baseline in body temperature
Measured: Baseline to Week 23
Change from baseline in pulse rate
Measured: Baseline to Week 23
Change from baseline in blood pressure
including systolic blood pressure and diastolic blood pressure
Measured: Baseline to Week 23
Change from baseline in ECG QTcF interval
Measured: Baseline to Week 23
Change from baseline in ECG RR interval
Measured: Baseline to Week 23
Change from baseline in ECG heart rate
Measured: Baseline to Week 23
Change from baseline in PHQ-9 total score
Measured: Baseline to Week 23
Change from baseline in C-SSRS score
Measured: Baseline to Week 23
Secondary outcomes (12)
Cmax
Measured: Baseline to Week 23
Tmax
Measured: Baseline to Week 23
AUC0-t
Measured: Baseline to Week23
AUC0-τ
Measured: Baseline to Week 23
Change from baseline in body weight
Measured: Baseline to Week 23
Change from baseline in Body Mass Index (BMI)
Measured: Baseline to Week 23
Change from baseline in Waist Circumference (WC)
Measured: Baseline to Week 23
Change from baseline in Waist-to-Hip Ratio (WHR)
Measured: Baseline to Week 23
Change from baseline in Glycated Hemoglobin (HbA1c)
Measured: Baseline to Day 92
Positive rate of anti-UBT37034 antibodies
Measured: Baseline to Week 23
Antibody titer levels in anti-UBT37034 antibody-positive participants
Measured: Baseline to Week 23
Positive rate of neutralizing antibodies (if applicable)
Measured: Baseline to Week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT07873645
- Sponsor's protocol ID
- TUL-UBT37034（I-2）202609
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Subcutaneous Administration of UBT37034 Injection in Overweight/Obesity Trial Participants
- ClinicalTrials.gov ID
- NCT07873645
- Acronym / sponsor ID
- TUL-UBT37034（I-2）202609
- Conditions
- Overweight , Obesity
- Keywords
- Overweight, Obesity, UBT37034, safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Oct 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 is a study of UBT37034 for injection in participants who have obesity or are overweight. The main purpose is to learn more about the safety, tolerability, drug concentration, drug action and immune response of repeated UBT37034 administration. This is a single-center, randomized, double-blind, placebo-controlled study with multiple ascending doses. A total of 40 participants will be enrolled in 4 different dose groups. Participants will receive UBT37034 or placebo in an 8:2 random ratio with dose titration. The study will last up to 24 weeks and includes screening, treatment and safety follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| UBT37034 Dose 1 | Experimental | Drug: UBT37034Participants will receive UBT37034 subcutaneously (SC). |
| UBT37034 Dose 2 | Experimental | Drug: UBT37034Participants will receive UBT37034 subcutaneously (SC). |
| UBT37034 Dose 3 | Experimental | Drug: UBT37034Participants will receive UBT37034 subcutaneously (SC). |
| UBT37034 Dose 4 | Experimental | Drug: UBT37034Participants will receive UBT37034 subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-55 years (inclusive) at the time of informed consent form (ICF) signing;
- BMI ≥24 kg/m² at screening; weight >60 kg (male) or >50 kg (female) at screening;
- Self-reported ≥3 months of diet and exercise control before screening, with ≤5% weight change in the prior 3 months;
- The participant (and partner) has no plan for pregnancy from screening until 6 months after study completion. The participant is willing to use study-specified contraception. No sperm or egg donation is permitted within 6 months after study completion;
- Fully understands the study and provides voluntary written informed consent.
Key exclusion criteria (41 listed)
- Suspected or confirmed hypersensitivity to components of products similar to the investigational product, or to any excipient of the investigational product; or subjects with allergic diathesis (multiple drug and food allergies).
- History of medication meeting any of the following criteria:
- 1）Use of prescription drugs, over-the-counter drugs, vitamin products, or herbal medicines within 14 days prior to screening or within at least 5 half-lives (whichever is longer); stable fixed-dose antihypertensive or lipid-lowering medications that have been taken for at least 1 month and have no impact on glucose metabolism and body weight are permitted； 2) received vaccination within 1 month before screening or planned to receive vaccination during the study; 3) used weight-modifying medications within 3 months before screening, including but not limited to marketed or investigational anti-obesity agents (e.g., GLP-1 analogues, orlistat), agents with mechanism similar to neuropeptide Y receptor agonists, tricyclic antidepressants, psychotropic agents or sedatives (e.g., mirtazapine, paroxetine, olanzapine, valproic acid and its derivatives); 4) used antihyperglycemic drugs within 3 months before screening (including but not limited to metformin, SGLT2 inhibitors, thiazolidinediones [TZDs], etc.) or agents that may alter glucose metabolism (e.g., systemic glucocorticoids, growth hormone).
- History or evidence of any of the following conditions:
- Abnormal laboratory findings at screening meeting any of the following:
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 |
|---|---|---|
| UBT37034Administered SC | Drug | UBT37034 Dose 1, UBT37034 Dose 2, UBT37034 Dose 3, UBT37034 Dose 4 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Baseline to Week23
Change from baseline in physical examinations
Time frame: Baseline to Week 23
Change from baseline in body temperature
Time frame: Baseline to Week 23
Change from baseline in pulse rate
Time frame: Baseline to Week 23
Change from baseline in blood pressure
Time frame: Baseline to Week 23
including systolic blood pressure and diastolic blood pressure
Change from baseline in ECG QTcF interval
Time frame: Baseline to Week 23
Change from baseline in ECG RR interval
Time frame: Baseline to Week 23
Change from baseline in ECG heart rate
Time frame: Baseline to Week 23
Change from baseline in PHQ-9 total score
Time frame: Baseline to Week 23
Change from baseline in C-SSRS score
Time frame: Baseline to Week 23
12 secondary outcomes
Cmax
Time frame: Baseline to Week 23
Tmax
Time frame: Baseline to Week 23
AUC0-t
Time frame: Baseline to Week23
AUC0-τ
Time frame: Baseline to Week 23
Change from baseline in body weight
Time frame: Baseline to Week 23
Change from baseline in Body Mass Index (BMI)
Time frame: Baseline to Week 23
Change from baseline in Waist Circumference (WC)
Time frame: Baseline to Week 23
Change from baseline in Waist-to-Hip Ratio (WHR)
Time frame: Baseline to Week 23
Change from baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline to Day 92
Positive rate of anti-UBT37034 antibodies
Time frame: Baseline to Week 23
Antibody titer levels in anti-UBT37034 antibody-positive participants
Time frame: Baseline to Week 23
Positive rate of neutralizing antibodies (if applicable)
Time frame: Baseline to Week 23
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 14 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UBT37034 in people with Overweight , Obesity, run by The United Bio-Technology (Hengqin) Co., Ltd..
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 41 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Guoping Yang (+86-13974817168, ygp9880@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Baseline to Week23). The study lists 10 primary outcomes in all. 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 14 Oct 2026.