Type 2 Diabetes Mellitus (T2DM)Phase 2T2DMNCT07163624
UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study
A Phase 2 study testing Semaglutide Injection (Ozempic®) in people with Type 2 Diabetes Mellitus (T2DM), run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes mellitus and to recommend the dosing regimen for the Phase III clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Semaglutide Injection (Ozempic®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2025to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 informed consent; sex not restricted.
- Documented diagnosis of type 2 diabetes mellitus with HbA1c ≥7.0% and ≤10.5% at screening.
- Lifestyle intervention or stable-dose metformin treatment (≥1000 mg/day) for at least 3 months before screening; "stable" defined as no change in daily dose during this period.
- Body weight: ≥50.0 kg for men and ≥45.0 kg for women at screening; body-mass index (BMI) 23.0-40.0 kg/m² (inclusive).
- Subject (and partner) agrees to use effective contraception from screening until 6 months after study completion and has no plans to donate sperm or ova during this period.
- Has been fully informed about the study and voluntarily signed the written informed consent form.
Who cannot join
- Known hypersensitivity to the investigational product or any of its excipients, to other GLP-1 receptor agonists, or history of clinically significant multiple or severe drug allergies; current allergic disease, high allergic disposition, or history of anaphylaxis.
- Prior use of any of the following medications:
- Any antihyperglycemic agent other than metformin within 3 months before screening, including GLP-1 analogues, oral antidiabetics, insulin, Chinese herbal medicines or health products with glucose-lowering effects.
- Systemic glucocorticoids, growth hormone, or any drug that may affect glucose metabolism within 3 months before screening.
- Any weight-loss medication within 3 months before screening.
- History or evidence of any of the following conditions:
Show all 43Show fewer
- Diabetes other than type 2 (e.g., type 1 diabetes, specific types of diabetes).
- Acute or chronic pancreatitis, or history of pancreatic surgery.
- Symptomatic gallbladder disease within 2 years before screening (imaging-confirmed gallstones with physician-diagnosed related abdominal pain); subjects with prior cholecystectomy without sequelae may be included.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- Hematologic disorders that may interfere with HbA1c measurement or increase subject risk, or any disease causing hemolysis or red-cell instability.
- History of depression or severe psychiatric disorders including suicidal ideation/attempt, schizophrenia, or bipolar disorder.
- Clinically significant active cardiovascular or cerebrovascular disease within 6 months before screening: myocardial infarction or unstable angina; cardiac surgery; congestive heart failure; cerebrovascular accident including stroke/TIA; any other cardiovascular/cerebrovascular condition deemed unsuitable by the investigator.
- Retinopathy requiring urgent treatment at screening.
- History of severe hypoglycemic coma or recurrent hypoglycemia within 2 months before randomization.
- Diabetic acute metabolic complications or diabetic foot within 6 months before screening.
- Gastroparesis or other disorders associated with delayed gastric emptying, uncontrolled gastro-esophageal reflux disease, or any gastrointestinal condition that, in the investigator's opinion, increases risk after study drug administration.
- Major surgery, severe trauma, or severe infection within 1 month before screening judged by the investigator to preclude study participation.
- History of malignancy (except adequately treated basal-cell carcinoma or carcinoma in situ of the cervix).
- Concurrent medical conditions (neurologic, endocrine, psychiatric, etc.) that, in the investigator's opinion, could compromise subject safety, affect efficacy assessments, or interfere with compliance.
- Clinically significant abnormal findings at screening, including:
- Fasting C-peptide <0.81 ng/mL.
- Hepatic or renal impairment: ALT and/or AST ≥2.5×ULN; total bilirubin ≥1.5×ULN; eGFR <60 mL·min-¹·1.73 m-².
- Serum calcitonin ≥50 pg/mL.
- Unstable thyroid medication requirement or clinically significant abnormal thyroid function tests necessitating new treatment.
- Fasting triglycerides ≥5.6 mmol/L.
- Serum amylase and/or lipase >2.0×ULN.
- INR above the upper limit of normal.
- Hemoglobin <110 g/L (males) or <100 g/L (females).
- Uncontrolled or untreated hypertension.
- Clinically significant ECG abnormalities: second- or third-degree AV block; long-QT syndrome or QTcF >470 ms (female) or >450 ms (male); pre-excitation syndrome; or any severe arrhythmia requiring treatment.
- Any physical examination, vital sign, or laboratory abnormality that, in the investigator's judgment, poses significant risk to the subject or may interfere with safety, PK, or PD evaluations.
- Positive tests for:
- HBsAg with HBV DNA above the reference range;
- Anti-HCV with HCV RNA above the ULN;
- HIV antibody;
- Treponemal antibody (syphilis).
- Blood loss or donation >400 mL, or receipt of blood/blood products within 3 months before screening; hemoglobinopathy, hemolytic anemia, or sickle-cell disease.
- Participation in another clinical trial within 3 months before screening.
- History of alcohol or drug abuse; alcohol abuse defined as >14 standard drinks per week (men) or >7 (women).
- Pregnant or lactating women.
- Inability to tolerate venipuncture, or history of vasovagal syncope or severe needle phobia.
- Any other condition that, in the investigator's opinion, renders the subject unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The United Bio-Technology (Hengqin) Co., Ltd.
Zhuhai, Guangdong, 519000
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes mellitus and to recommend the dosing regimen for the Phase III clinical trial.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- UBT251 Injection 2.0 mg and UBT251 Injection Placebo, UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection Placebo, UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo, UBT251 Injection 6.0 mg and UBT251 Injection Placebo, Semaglutide Injection (Ozempic®)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT251 Injection 2.0 mg and UBT251 Injection PlaceboDrug
UBT251 Injection and UBT251 Injection Placebo once weekly
UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection PlaceboDrug
UBT251 Injection and UBT251 Injection Placebo once weekly
UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection PlaceboDrug
UBT251 Injection and UBT251 Injection Placebo once weekly
UBT251 Injection 6.0 mg and UBT251 Injection PlaceboDrug
UBT251 Injection and UBT251 Injection Placebo once weekly
Semaglutide Injection (Ozempic®)Drug
Semaglutide Injection (Ozempic®) once weekly
| Study group | Role | What they receive |
|---|---|---|
| UBT251 Injection 2.0 mg | Experimental | Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9weeks to 1.0 mg and 2.0 mg once weekly. Receives: Drug: UBT251 Injection 2.0 mg and UBT251 Injection Placebo |
| UBT251 Injection 4.0 mg（ID 0.5 mg） | Experimental | Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 1.0 mg, 2.0 mg and 4.0 mg once weekly. Receives: Drug: UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection Placebo |
| UBT251 Injection 4.0 mg（ID 1.0 mg） | Experimental | Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 2.0 mg and 4.0 mg once weekly. Receives: Drug: UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo |
| UBT251 Injection 6.0 mg | Experimental | Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 2.0 mg, 4.0 mg and 6.0 mg once weekly. Receives: Drug: UBT251 Injection 6.0 mg and UBT251 Injection Placebo |
| Semaglutide Injection （Ozempic®）1.0 mg | Active comparator | Each subject will receive Semaglutide Injection （Ozempic®）, s.c. once weekly for 24 weeks. The starting dose of Semaglutide Injection （Ozempic®） will be 0.25 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 0.5 mg and 1.0 mg once weekly. Receives: Drug: Semaglutide Injection (Ozempic®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c at Week 24
HbA1c was obtained at baseline and at Week 24
Measured: Baseline to week 24
Secondary outcomes (12)
Change Change from baseline to week 12, 16, 20 in HbA1c
HbA1c was obtained at baseline and at Week 12, 16, 20
Measured: Week 12, 16, 20
Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24
FPG was obtained at baseline and at Week 12, 16, 20, 24
Measured: Week 12, 16, 20, 24
Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24
2-hour post-standard-meal plasma glucose was obtained at baseline and at Week 12, 24
Measured: Week 12, 24
Change in body weight from baseline to week 12, 24
Body Weight was obtained at baseline and at Week 12, 24
Measured: Week 12, 24
Change in waist circumference from baseline to week 12, 24
Waist circumference was obtained at baseline and at Week 12, 24
Measured: Week 12, 24
HbA1c target achievement rates (<7.0%) at Week 24
Percentage of participants who achieved HbA1c <7.0% is presented
Measured: Week 24
HbA1c target achievement rates (≤6.5%) at Week 24
Percentage of participants who achieved HbA1c ≤6.5% is presented
Measured: Week 24
FPG target achievement rate (4.4-7.0 mmol/L) at Week 24
Percentage of FPG target achievement (4.4-7.0 mmol/L) at Week 24
Measured: Week 24
Combined target achievement rate for both HbA1c and FPG at Week 24
Percentage of Combined target achievement rate for both HbA1c and FPG at Week 24
Measured: Week 24
Change from baseline to week 24 in fasting lipid profile
Fasting lipid profile was obtained at baseline and at Week 24
Measured: Week 24
Change from baseline to week 24 in systolic blood pressure
Systolic blood pressure was obtained at baseline and at Week 24
Measured: Week 24
Change from baseline to week 24 in diastolic blood pressure
Diastolic blood pressure was obtained at baseline and at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start22 Mar 2025
- Primary completion21 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
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
- NCT07163624
- Sponsor's protocol ID
- TUL-UBT251(Ⅱ-2)202405
- Other IDs
- CTR20250029
- Acronym
- T2DM
- Status last verified
- May 2026
- First submitted
- 1 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhou Z, Shi X, Jiang S, Wang S, Shu H, Sun W, Wang H, Cong L, Mao L, Fu L, Gan S, Zhang L, Han J, Gao Y, Wang W, Zhang L, Wang F, Cao C, Yan X, Zhang H, Su T, Ling W, Jakobsen LHK, Belmar Nazal N, Yan H. UBT251, a novel triple GLP-1, GIP, and glucagon receptor agonist, in adults with type 2 diabetes: A multicenter, randomized phase 2 trial. Cell Metab. 2026 Oct 26:S1550-4131(26)00447-X. doi: 10.1016/j.cmet.2026.10.010. Online ahead of print.
PubMed 42933400
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07163624
- Acronym / sponsor ID
- T2DM / TUL-UBT251(Ⅱ-2)202405
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 9 Sep 2025 (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.
The purpose of this study is to evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes mellitus and to recommend the dosing regimen for the Phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| UBT251 Injection 2.0 mg | Experimental | Drug: UBT251 Injection 2.0 mg and UBT251 Injection PlaceboEach subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9weeks to 1.0 mg and 2.0 mg once weekly. |
| UBT251 Injection 4.0 mg（ID 0.5 mg） | Experimental | Drug: UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection PlaceboEach subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 1.0 mg, 2.0 mg and 4.0 mg once weekly. |
| UBT251 Injection 4.0 mg（ID 1.0 mg） | Experimental | Drug: UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection PlaceboEach subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 2.0 mg and 4.0 mg once weekly. |
| UBT251 Injection 6.0 mg | Experimental | Drug: UBT251 Injection 6.0 mg and UBT251 Injection PlaceboEach subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 2.0 mg, 4.0 mg and 6.0 mg once weekly. |
| Semaglutide Injection （Ozempic®）1.0 mg | Active comparator | Drug: Semaglutide Injection (Ozempic®)Each subject will receive Semaglutide Injection （Ozempic®）, s.c. once weekly for 24 weeks. The starting dose of Semaglutide Injection （Ozempic®） will be 0.25 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 0.5 mg and 1.0 mg once weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years (inclusive) at the time of informed consent; sex not restricted.
- Documented diagnosis of type 2 diabetes mellitus with HbA1c ≥7.0% and ≤10.5% at screening.
- Lifestyle intervention or stable-dose metformin treatment (≥1000 mg/day) for at least 3 months before screening; "stable" defined as no change in daily dose during this period.
- Body weight: ≥50.0 kg for men and ≥45.0 kg for women at screening; body-mass index (BMI) 23.0-40.0 kg/m² (inclusive).
- Subject (and partner) agrees to use effective contraception from screening until 6 months after study completion and has no plans to donate sperm or ova during this period.
Key exclusion criteria (43 listed)
- Known hypersensitivity to the investigational product or any of its excipients, to other GLP-1 receptor agonists, or history of clinically significant multiple or severe drug allergies; current allergic disease, high allergic disposition, or history of anaphylaxis.
- Prior use of any of the following medications:
- History or evidence of any of the following conditions:
- Clinically significant abnormal findings at screening, including:
- Positive tests for:
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 2.0 mg and UBT251 Injection PlaceboUBT251 Injection and UBT251 Injection Placebo once weekly | Drug | UBT251 Injection 2.0 mg |
| UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection PlaceboUBT251 Injection and UBT251 Injection Placebo once weekly | Drug | UBT251 Injection 4.0 mg（ID 0.5 mg） |
| UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection PlaceboUBT251 Injection and UBT251 Injection Placebo once weekly | Drug | UBT251 Injection 4.0 mg（ID 1.0 mg） |
| UBT251 Injection 6.0 mg and UBT251 Injection PlaceboUBT251 Injection and UBT251 Injection Placebo once weekly | Drug | UBT251 Injection 6.0 mg |
| Semaglutide Injection (Ozempic®)Semaglutide Injection (Ozempic®) once weekly | Drug | Semaglutide Injection （Ozempic®）1.0 mg |
Primary outcome
Change From Baseline in HbA1c at Week 24
Time frame: Baseline to week 24
HbA1c was obtained at baseline and at Week 24
12 secondary outcomes
Change Change from baseline to week 12, 16, 20 in HbA1c
Time frame: Week 12, 16, 20
Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24
Time frame: Week 12, 16, 20, 24
Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24
Time frame: Week 12, 24
Change in body weight from baseline to week 12, 24
Time frame: Week 12, 24
Change in waist circumference from baseline to week 12, 24
Time frame: Week 12, 24
HbA1c target achievement rates (<7.0%) at Week 24
Time frame: Week 24
HbA1c target achievement rates (≤6.5%) at Week 24
Time frame: Week 24
FPG target achievement rate (4.4-7.0 mmol/L) at Week 24
Time frame: Week 24
Combined target achievement rate for both HbA1c and FPG at Week 24
Time frame: Week 24
Change from baseline to week 24 in fasting lipid profile
Time frame: Week 24
Change from baseline to week 24 in systolic blood pressure
Time frame: Week 24
Change from baseline to week 24 in diastolic blood pressure
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42933400Zhou Z, Shi X, Jiang S, Wang S, Shu H, Sun W, Wang H, Cong L, Mao L, Fu L, Gan S, Zhang L, Han J, Gao Y, Wang W, Zhang L, Wang F, Cao C, Yan X, Zhang H, Su T, Ling W, Jakobsen LHK, Belmar Nazal N, Yan H. UBT251, a novel triple GLP-1, GIP, and glucagon receptor agonist, in adults with type 2 diabetes: A multicenter, randomized phase 2 trial. Cell Metab. 2026 Oct 26:S1550-4131(26)00447-X. doi: 10.1016/j.cmet.2026.10.010. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide Injection (Ozempic®) in people with Type 2 Diabetes Mellitus (T2DM), 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 6 inclusion and 43 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: finished, as of the sponsor's last update on 21 Sep 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c at Week 24 (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163624, which also lists 1 linked publication.
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 21 Sep 2026.