Adolescence ObesityPhase 1NCT07693426
Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
A Phase 1 study testing Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW and Efsubaglutide Alfa 20 mg QW in people with Adolescence Obesity, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 5 sites in China.
Trial summary
This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescence Obesity
- What is being tested?
- Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW and Efsubaglutide Alfa 20 mg QW
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 5 sitesChina
- Study dates
- 16 Jul 2026to 31 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Informed consent must be obtained from the participant's parent or legally authorized representative and assent from the adolescent participant before any study-related procedures.
- 2. Adolescent participants aged ≥12 years and <18 years (at the time of informed consent).
- 3. At screening, meet the obesity criteria defined in "WS/T586-2018 Screening for Overweight and Obesity among School-age Children and Adolescents".
- 4. Before screening, have been on dietary and exercise control alone for at least 3 months with <5.0% reduction in body mass index (based on self-report or report by parent or legally authorized representative).
- 5.Must be willing to follow the diet and exercise guidance and able to maintain such stable diet and exercise lifestyle during the study period.
- 6. Female participants of childbearing potential must have a negative serum pregnancy test at screening.
- 7. Able to understand all study procedures, willing to strictly comply with the study protocol, complete the study visits as scheduled, and finish the study.
Who cannot join
- 1. Pre-pubertal participants (Tanner Stage I).
- 2. History of severe allergic reactions or suspected allergy to study drug or its ingredients.
- 3. Pregnant or lactating women; men or women of childbearing potential planning pregnancy or unwilling to use highly effective contraception throughout the study.
- 4. Use of weight-affecting medications before screening.
- 5. Known monogenic obesity, obesity caused by other diseases or medications,
- 6. Previously diagnosed Type 1 diabetes, Type 2 diabetes, or special types of diabetes;
Show all 21Show fewer
- 7. history of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥2 times within half a year).
- 8. Clinically significant gastric emptying abnormalities, severe chronic gastrointestinal diseases, long-term use of medications directly affecting gastrointestinal motility, or gastrointestinal surgery within 6 months prior to screening, deemed unsuitable for the study by the investigator.
- 9. History of malignancy within 5 years prior to screening, excluding clinically cured cervical intraepithelial neoplasia, squamous cell carcinoma, or basal cell carcinoma within 5 years.
- 10. Major surgery within 6 months prior to screening, or planned surgery during the study that may affect study completion or compliance;
- 11. history of bariatric surgery or planned bariatric surgery during the study (e.g., gastric bypass, gastric banding).
- 12. History of acute or chronic pancreatitis, symptomatic gallbladder disease at screening, history of pancreatic injury, or other high-risk factors for pancreatitis; or amylase or lipase >2.0×ULN at screening.
- 13. Known or suspected drug/substance abuse at screening; positive HBsAg;
- 14. Positive HCV antibody with HCV RNA above the lower limit of detection; positive HIV antibody; positive Tp-Ab.
- 15. Currently receiving or received chronic (>14 days) systemic glucocorticoid therapy within 3 months prior to screening, or evidence of severe active autoimmune disease that may require systemic glucocorticoid therapy within the next 12 months as judged by the investigator.
- 16. History of hyperthyroidism or hypothyroidism, or TSH <1.0×LLN, or TSH >1.5×ULN, or history of medullary thyroid carcinoma.
- 17. Serum calcitonin ≥50 ng/L (pg/mL) at screening; ALT >3.0×ULN, or AST >3.0×ULN, or total bilirubin >2.0×ULN; eGFR <60 mL/min/1.73 m² at screening; fasting triglycerides ≥5.64 mmol/L (500 mg/dL).
- 18. Blood donation and/or blood loss ≥400 mL or bone marrow donation within 3 months prior to screening, or presence of hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin <118 g/L (ages 12-<13 years), <129 g/L (males ≥13 years), or <114 g/L (females ≥13 years).
- 19. Participation in vaccine or medical device clinical trials within 3 months prior to screening, or any drug clinical trial within less than 3 months or 5 half-lives (whichever is longer).
- 20. History of moderate to severe depression, anxiety disorder, or severe psychiatric illness.
- 21. Any other condition that, in the opinion of the investigator, may affect the participant's safety or compliance with the study protocol.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality
Guang Wang
- Not yet recruiting
Qilu Hospital, Shandong University
Jinan, Shandong
Xinguo Hou
Shuwen Yu
- Recruiting
Qilu Second Hospital, Shandong University
Jinan, Shandong
Shuang Liang
Deqing Sun
- Not yet recruiting
Shengjing Hospital, China Medical University
Shenyang, Liaoning
Xiaoguang Shi
- Not yet recruiting
Wuhan Central Hospital
Wuhan, Hubei
Weihua Wang
Zhongjing Wang
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Efsubaglutide Alfa in Chinese Adolescents With Obesity
This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity.
Read the detailed description
The prevalence of obesity in adolescents is rising and threatening physiological and psychological health. Different from adults with obesity, there is still no approved drug to manage the obesity in adolescents, In order to provide the therapeutical option earlier, the weight-reduction study in obese adolescents is planned. The primary objective of this Phase Ib study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of multiple doses of Efsubaglutide Alfa at different dose levels in Chinese adolescent participants with obesity. The secondary objectives include the evaluations of the pharmacodynamic (PD) effects, PK-PD relationship , and immunogenicity of multiple doses of Efsubaglutide Alfa at different dose levels. This randomized, double-blind, placebo-controlled, parallel-group study will enroll a total of 36 adolescent participants aged 12 to 17 years with obesity . 36 participants will be randomized in a 3:1 ratio to receive Efsubaglutide Alfa or placebo administered subcutaneously once weekly (QW) for up to 12 weeks. Safety will be monitored throughout the study by assessment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESI), laboratory parameters, vital signs, and 12-lead electrocardiograms.
- Conditions
- Adolescence Obesity
- Being tested
- Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW, Efsubaglutide Alfa 20 mg QW, Efsubaglutide Alfa placebo
- Keywords
- Efsubaglutide Alfa, GLP-1 receptor agonist, Adolescent Obesity, weight loss
- Medical subject headings
- Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efsubaglutide Alfa 5 mg QWDrug
Efsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa 10 mg QWDrug
Efsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa 20 mg QWDrug
Efsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa placeboDrug
Efsubaglutide Alfa placebo Injection Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Efsubaglutide Alfa 5 mg QW | Experimental | Efsubaglutide Alfa, 5 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen Receives: Drug: Efsubaglutide Alfa 5 mg QW |
| Efsubaglutide Alfa 10 mg QW | Experimental | Efsubaglutide Alfa, 10 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen Receives: Drug: Efsubaglutide Alfa 10 mg QW |
| Efsubaglutide Alfa 20 mg QW | Experimental | Efsubaglutide Alfa, 20 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen Receives: Drug: Efsubaglutide Alfa 20 mg QW |
| Efsubaglutide Alfa placebo | Placebo comparator | Efsubaglutide Alfa placebo, once weekly，12 weeks Solution for injection in pre-filled auto-injector pen Receives: Drug: Efsubaglutide Alfa placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Safety and tolerability assessed by monitoring treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESI) throughout the study
Measured: Throughout the study (up to Week 18)
Pharmacokinetic (PK) characteristics at steady state following multiple doses
PK parameters including plasma drug concentrations at steady state following multiple-dose administration of Efsubaglutide Alfa
Measured: Throughout the study (up to Week 18)
Secondary outcomes (19)
Change in body mass index (BMI) from baseline (absolute and percentage)
Change in BMI from baseline at Week 12, measured as absolute value and percentage change
Measured: Week 12
Change in BMI from baseline over time (absolute and percentage)
Change in BMI from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change
Measured: Weeks 4, 8, and 12
Change in fasting body weight from baseline (absolute and percentage)
Change in fasting body weight from baseline at Week 12, measured as absolute value and percentage change
Measured: Week 12
Change in fasting body weight from baseline over time (absolute and percentage)
Change in fasting body weight from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change
Measured: Weeks 4, 8, and 12
Change in waist circumference from baseline
Change in waist circumference from baseline at Week 12
Measured: Week 12
Change in hip circumference from baseline
Change in hip circumference from baseline at Week 12
Measured: Week 12
Change in waist-to-hip ratio (WHR) from baseline
Change in waist-to-hip ratio (WHR) from baseline at Week 12
Measured: Week 12
Change in waist-to-height ratio from baseline
Change in waist-to-height ratio from baseline at Week 12
Measured: Week 12
Proportion of participants achieving ≥5%, ≥10%, and ≥15% reduction in BMI and/or fasting body weight from baseline
Measured: Week 12
Change in systolic blood pressure and diastolic blood pressure from baseline
Measured: Week 12
Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline
Measured: Week 12
Change in fasting blood glucose from baseline
Measured: Week 12
Change in HbA1c from baseline
Measured: Week 12
Change in fasting insulin from baseline
Measured: Week 12
Change in blood uric acid from baseline
Measured: Week 12
The correlation between Efsubaglutide Alfa Cmax, ss and BMI
Measured: Throughout the study (up to Week 18)
The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI
Measured: Throughout the study (up to Week 18)
Incidence, titer, and persistence of anti-drug antibodies (ADA)
Measured: Throughout the study (up to Week 18)
Incidence, titer, and persistence of neutralizing antibodies
Measured: Throughout the study (up to Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start16 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescence 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
- Model description
- Three dose cohorts (5 mg, 10 mg, 20 mg QW) with intra-cohort 3:1 active-to-placebo randomization; all cohorts include a dose-titration phase followed by atarget-dose 12-week maintenance period for 12 weeks treatment in total (including dose titration and dose maintenance period).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693426
- Sponsor's protocol ID
- YN012Y-Ib-W102
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Efsubaglutide Alfa in Chinese Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT07693426
- Acronym / sponsor ID
- YN012Y-Ib-W102
- Conditions
- Adolescence Obesity
- Keywords
- Efsubaglutide Alfa, GLP-1 receptor agonist, Adolescent Obesity, weight loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.University, hospital or other
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Jul 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 Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity.
Detailed description
The prevalence of obesity in adolescents is rising and threatening physiological and psychological health. Different from adults with obesity, there is still no approved drug to manage the obesity in adolescents, In order to provide the therapeutical option earlier, the weight-reduction study in obese adolescents is planned. The primary objective of this Phase Ib study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of multiple doses of Efsubaglutide Alfa at different dose levels in Chinese adolescent participants with obesity. The secondary objectives include the evaluations of the pharmacodynamic (PD) effects, PK-PD relationship , and immunogenicity of multiple doses of Efsubaglutide Alfa at different dose levels. This randomized, double-blind, placebo-controlled, parallel-group study will enroll a total of 36 adolescent participants aged 12 to 17 years with obesity . 36 participants will be randomized in a 3:1 ratio to receive Efsubaglutide Alfa or placebo administered subcutaneously once weekly (QW) for up to 12 weeks. Safety will be monitored throughout the study by assessment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESI), laboratory parameters, vital signs, and 12-lead electrocardiograms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Three dose cohorts (5 mg, 10 mg, 20 mg QW) with intra-cohort 3:1 active-to-placebo randomization; all cohorts include a dose-titration phase followed by atarget-dose 12-week maintenance period for 12 weeks treatment in total (including dose titration and dose maintenance period).
| Arm | Type | Receives |
|---|---|---|
| Efsubaglutide Alfa 5 mg QW | Experimental | Drug: Efsubaglutide Alfa 5 mg QWEfsubaglutide Alfa, 5 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen |
| Efsubaglutide Alfa 10 mg QW | Experimental | Drug: Efsubaglutide Alfa 10 mg QWEfsubaglutide Alfa, 10 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen |
| Efsubaglutide Alfa 20 mg QW | Experimental | Drug: Efsubaglutide Alfa 20 mg QWEfsubaglutide Alfa, 20 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen |
| Efsubaglutide Alfa placebo | Placebo comparator | Drug: Efsubaglutide Alfa placeboEfsubaglutide Alfa placebo, once weekly，12 weeks Solution for injection in pre-filled auto-injector pen |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 1. Informed consent must be obtained from the participant's parent or legally authorized representative and assent from the adolescent participant before any study-related procedures.
- 2. Adolescent participants aged ≥12 years and <18 years (at the time of informed consent).
- 3. At screening, meet the obesity criteria defined in "WS/T586-2018 Screening for Overweight and Obesity among School-age Children and Adolescents".
- 4. Before screening, have been on dietary and exercise control alone for at least 3 months with <5.0% reduction in body mass index (based on self-report or report by parent or legally authorized representative).
- 5.Must be willing to follow the diet and exercise guidance and able to maintain such stable diet and exercise lifestyle during the study period.
Key exclusion criteria (21 listed)
- 1. Pre-pubertal participants (Tanner Stage I).
- 2. History of severe allergic reactions or suspected allergy to study drug or its ingredients.
- 3. Pregnant or lactating women; men or women of childbearing potential planning pregnancy or unwilling to use highly effective contraception throughout the study.
- 4. Use of weight-affecting medications before screening.
- 5. Known monogenic obesity, obesity caused by other diseases or medications,
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 |
|---|---|---|
| Efsubaglutide Alfa 5 mg QWEfsubaglutide Alfa Injection Subcutaneous injection | Drug | Efsubaglutide Alfa 5 mg QW |
| Efsubaglutide Alfa 10 mg QWEfsubaglutide Alfa Injection Subcutaneous injection | Drug | Efsubaglutide Alfa 10 mg QW |
| Efsubaglutide Alfa 20 mg QWEfsubaglutide Alfa Injection Subcutaneous injection | Drug | Efsubaglutide Alfa 20 mg QW |
| Efsubaglutide Alfa placeboEfsubaglutide Alfa placebo Injection Subcutaneous injection | Drug | Efsubaglutide Alfa placebo |
Primary outcome
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Time frame: Throughout the study (up to Week 18)
Safety and tolerability assessed by monitoring treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESI) throughout the study
Pharmacokinetic (PK) characteristics at steady state following multiple doses
Time frame: Throughout the study (up to Week 18)
PK parameters including plasma drug concentrations at steady state following multiple-dose administration of Efsubaglutide Alfa
19 secondary outcomes
Change in body mass index (BMI) from baseline (absolute and percentage)
Time frame: Week 12
Change in BMI from baseline over time (absolute and percentage)
Time frame: Weeks 4, 8, and 12
Change in fasting body weight from baseline (absolute and percentage)
Time frame: Week 12
Change in fasting body weight from baseline over time (absolute and percentage)
Time frame: Weeks 4, 8, and 12
Change in waist circumference from baseline
Time frame: Week 12
Change in hip circumference from baseline
Time frame: Week 12
Change in waist-to-hip ratio (WHR) from baseline
Time frame: Week 12
Change in waist-to-height ratio from baseline
Time frame: Week 12
Proportion of participants achieving ≥5%, ≥10%, and ≥15% reduction in BMI and/or fasting body weight from baseline
Time frame: Week 12
Change in systolic blood pressure and diastolic blood pressure from baseline
Time frame: Week 12
Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline
Time frame: Week 12
Change in fasting blood glucose from baseline
Time frame: Week 12
Change in HbA1c from baseline
Time frame: Week 12
Change in fasting insulin from baseline
Time frame: Week 12
Change in blood uric acid from baseline
Time frame: Week 12
The correlation between Efsubaglutide Alfa Cmax, ss and BMI
Time frame: Throughout the study (up to Week 18)
The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI
Time frame: Throughout the study (up to Week 18)
Incidence, titer, and persistence of anti-drug antibodies (ADA)
Time frame: Throughout the study (up to Week 18)
Incidence, titer, and persistence of neutralizing antibodies
Time frame: Throughout the study (up to Week 18)
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 30 Jul 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW and Efsubaglutide Alfa 20 mg QW in people with Adolescence Obesity, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 5 sites 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 7 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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 QINGHUA WANG, M.D,Ph.D (+862168788225, dr.qwang@innogenpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: incidence of TEAEs, SAEs, and AESI (time frame: Throughout the study (up to Week 18)). The study lists 2 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 30 Jul 2026.