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Obesity and OverweightPhase 2/3NCT06921486

The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (ENLIGHT)

A Phase 2/3 study testing Phase IIb:Efsubaglutide Alfa 5 mg QW, Phase IIb:Efsubaglutide Alfa 10 mg QW and Phase IIb:Efsubaglutide Alfa 20 mg QW in people with Obesity and Overweight, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 41 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III clinical trial aimed at evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity profile of Efsubaglutide Alfa injection in overweight and obese subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity and Overweight
What is being tested?
Phase IIb:Efsubaglutide Alfa 5 mg QW, Phase IIb:Efsubaglutide Alfa 10 mg QW and Phase IIb:Efsubaglutide Alfa 20 mg QW
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,003 participants
Where
41 sitesChina
Study dates
31 Mar 2025to 31 Dec 2026
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the clinical study; fully understand and be informed about the study, and sign the informed consent form (ICF); willing to follow and capable of completing all study procedures.
  • Age ≥ 18 years (including the cutoff value, based on the time of signing the ICF), regardless of gender.
  • History of poor weight control through diet and exercise [defined as weight control failure if the subject has attempted at least 3 months of diet and exercise alone prior to screening without achieving a weight loss of ≥ 5.0% (based on subject self-report)].
  • Willing to follow the recommendations of the investigator regarding medication, diet, and exercise.
  • Stable weight within 3 months prior to screening (defined as a weight change < 5%, based on subject self-report).
  • Obesity: Body Mass Index (BMI) ≥ 28 kg/m² (including the cutoff value) with or without comorbidities; or overweight: BMI ≥ 24 and < 28 kg/m² with at least one weight-related comorbidity, including but not limited to prediabetes (impaired fasting glucose [FPG] and/or abnormal glucose tolerance), hypertension, dyslipidemia, non-alcoholic fatty liver disease, or obstructive sleep apnea syndrome.
  • Women of childbearing potential must have a negative blood pregnancy test during the screening period. Women of childbearing potential or male subjects and their partners must agree not to plan for pregnancy from the time of signing the ICF until 3 months after the last dose of the investigational drug, and voluntarily agree to use effective contraception, with no plans for sperm or egg donation.

Who cannot join

  • Allergic constitution or allergic to any component of the investigational drug.
  • Previously treated with Efsubaglutide Alfa injection.
  • Received glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulin, metformin, insulin secretagogues, or thiazolidinediones (TZD) or any other weight-affecting anti-diabetic medication within the past 3 months before screening.
  • HbA1c ≥ 6.5% at screening, or previously diagnosed with Type 1 or Type 2 diabetes (based on the World Health Organization [WHO] 2020 diabetes diagnosis and classification standards).
  • History of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 times in the past 6 months).
  • Known single-gene mutations, other diseases, or drug-induced obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, growth hormone deficiency, acromegaly, pseudohypoparathyroidism, gonadal dysfunction, etc.
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  • Clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., active ulcers in the past 6 months), long-term use of drugs directly affecting gastrointestinal motility (including but not limited to mosapride, cisapride, etc.), or having undergone gastrointestinal surgery within the past 6 months and deemed unsuitable for participation by the investigator.
  • Use of weight-affecting medications within 3 months prior to screening, including tricyclic antidepressants, psychiatric medications, or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, sulpiride, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts, etc.). Note: Excluded if cumulative or continuous systemic steroid use is less than 14 days.
  • Use of non-prescription weight loss medications or appetite suppressants (including traditional Chinese medicine weight loss drugs) within 1 month prior to screening, or use of prescription weight loss medications (e.g., phentermine, sibutramine, orlistat) or lipid-dissolving injectables (e.g., lipolytic injections) within 3 months prior to screening.
  • Previously underwent weight-loss surgery (excluding acupuncture, liposuction, and abdominal fat removal within 1 year before screening), or plans to undergo surgery for obesity during the study period, such as gastric bypass surgery or gastric band surgery.
  • Currently on a weight loss plan and not in the maintenance phase.
  • History of hyperthyroidism or hypothyroidism, or thyroid-stimulating hormone (TSH) < 1×LLN (lower limit of normal) or TSH > 1.5×ULN (upper limit of normal).
  • Screening serum calcitonin ≥ 50 ng/L (or ≥ 50 pg/mL), or history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) syndrome type 2A or 2B, or related family history (family history defined as a first-degree relative with the disease).
  • History of acute or chronic pancreatitis, cholecystectomy, or symptomatic gallbladder disease (patients with post-surgery resolved gallstones or cholecystectomy without sequelae can be enrolled), or known history of pancreatic injury or high-risk factors for pancreatitis, or screening with serum amylase or lipase > 2×ULN.
  • Any disease that could affect HbA1c measurement, such as hemolytic anemia, sickle cell disease, etc.
  • Currently receiving or have received chronic (> 14 days) systemic corticosteroid treatment in the past 3 months (excluding local, intraocular, intranasal, intra-articular, or inhaled formulations), or have evidence of severe, active autoimmune disorders (e.g., lupus or rheumatoid arthritis), and, in the opinion of the investigator, require or may require systemic corticosteroid treatment within the next 12 months.
  • History of malignancy within 5 years prior to screening, excluding clinically cured cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma within the past 5 years.
  • History of major surgery (e.g., thoracic, intracranial, or abdominal surgery) within 6 months prior to screening, or plans to undergo surgery that may affect study completion or adherence.
  • Meets any of the following cardiac function criteria: clinically significant arrhythmias or conduction abnormalities requiring clinical intervention; hereditary long QT syndrome or QTcF > 450 msec or currently taking medications that may prolong the QT interval or cause torsades de pointes; clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, coronary artery bypass graft surgery, New York Heart Association (NYHA) class III or higher congestive heart failure, left ventricular ejection fraction (LVEF) < 50%, or uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); other clinically significant cardiac abnormalities judged by the investigator.
  • History of hemorrhagic or ischemic stroke or transient ischemic attack within 6 months prior to screening.
  • Known infectious diseases: hepatitis B surface antigen (HBsAg) positive; hepatitis C virus (HCV) antibody positive and HCV RNA above the detection limit; human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
  • Laboratory findings meeting any of the following: alanine aminotransferase (ALT) ≥ 3.0×ULN (subjects diagnosed with non-alcoholic fatty liver disease during screening and within the past 6 months with ALT ≤ 5.0×ULN may be enrolled); aspartate aminotransferase (AST) ≥ 3.0×ULN; total bilirubin (TBIL) ≥ 2.0×ULN; estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² (CKD-EPI formula); fasting triglycerides (TG) > 5.65 mmol/L.
  • Known or suspected alcohol abuse within 1 year prior to screening (defined as male subjects consuming > 24 g alcohol per day, female subjects consuming > 12 g alcohol per day; 12 g alcohol is approximately equivalent to 300 mL beer, 100 mL wine, or 25 mL spirits).
  • Known or suspected drug abuse at screening.
  • Pregnant or breastfeeding women.
  • History of moderate to severe depression, anxiety, or serious mental disorders, such as schizophrenia, bipolar disorder, etc., or screening PHQ-9 score ≥ 15.
  • History of suicidal tendencies or suicide attempts.
  • Participation in a clinical trial involving vaccines, medical devices, or other drugs within 3 months prior to screening (except for observational studies).
  • The investigator or treating physician considers that the subject has any factors that may affect the evaluation of the efficacy or safety of the study, and is deemed unsuitable for participation in the study.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

China41 sites
  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Tsinghua Changgung Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • Changzhou First People's Hospital

    Changzhou

  • Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital

    Chengdu

  • Nanfang Hospital Southern Medical University

    Guangzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • The First Affiliateo Hospital of Jinan University

    Guangzhou

  • Zhujiang Hospital of Southern Medical University

    Guangzhusi

  • The First People'S Hospital of Zunyi

    Guizhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • Anhui Provincial Hospital

    Hefei

  • The First Affiliated Hospital of Henan University of Science and Technology

    Henan

  • The First Affiliated Hospital of Nanyang Medical College

    Henan

  • Pingxiang People's Hospital

    Jiangxi

  • Jincheng General Hospital

    Jincheng

  • The Third Affiliated Hospital

    Jinzhou

  • The First People's Hospital of Yunnan Province

    Kunming

  • Luan City People's Hospital

    Lu'an

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing

  • Nan Jing First Hospital

    Nanjing

  • The Second Hospital of Nanjing Medical University

    Nanjing

  • The Affiliated Qingyuan Hospital ,Guangzhou Medical University(Qingyuan People's Hospital)

    Qingyuan

  • The First Hospital of Qinhuangdao

    Qinhuangdao

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Shandong

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

    Shanghai, 200030

  • Shanghai General Hospital

    Shanghai

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

  • The First Hospital Of China Medical University

    Shenyang

  • Shenzhen Second People's Hospital

    Shenzhen

  • The First Hospital of Hebei Medical University

    Shijiazhuang

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

  • Suzhou Municipal Hospital

    Suzhou

  • The Second Affiliated Hospital of Soochow University

    Suzhou

  • General Hospital of Tianjin Medical University

    Tianjin

  • Tianjin Medical University Chu Hsien-I Memorial Hospital

    Tianjin

  • Tenth People's Hospital Of Tongji University

    Wuhan

  • Wuhan Third Hospital Tongren Hospital of Wuhan University

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xianian

  • Yueyang Central Hospital

    Yueyang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Clinical Trial to Evaluate the Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects

This study is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III clinical trial aimed at evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity profile of Efsubaglutide Alfa injection in overweight and obese subjects. The primary endpoint of the Phase IIb is the percentage change in body weight from baseline after 18 weeks of treatment. The primary endpoint of the Phase III is the percentage change in body weight from baseline after 30 weeks of treatment, the secondary endpoint is the percentage change in body weight from baseline after a cumulative 48 weeks of treatment.

Being tested
Phase IIb:Efsubaglutide Alfa 5 mg QW, Phase IIb:Efsubaglutide Alfa 10 mg QW, Phase IIb:Efsubaglutide Alfa 20 mg QW, Phase IIb:Efsubaglutide Alfa 20 mg Q2W, Phase IIb:Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phase IIb:Efsubaglutide Alfa 5 mg QWDrug

    IIb:Efsubaglutide Alfa 5 mg QW

  • Phase IIb:Efsubaglutide Alfa 10 mg QWDrug

    Efsubaglutide Alfa 10 mg QW

  • Phase IIb:Efsubaglutide Alfa 20 mg QWDrug

    Efsubaglutide Alfa 20 mg QW

  • Phase IIb:Efsubaglutide Alfa 20 mg Q2WDrug

    Efsubaglutide Alfa 20 mg Q2W

  • Phase IIb:PlaceboDrug

    Placebo

  • Phase III:Recommended Phase 3 Dose High DoseDrug

    The Recommended Phase 3 Dose High Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.

  • Phase III:Recommended Phase 3 Dose Low DoseDrug

    The Recommended Phase 3 Dose Low Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.

  • Phase III:PlaceboDrug

    Placebo

Study groups in NCT06921486
Study groupRoleWhat they receive
Phase IIb:Efsubaglutide Alfa 5 mg QWExperimentalThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg, reaching the target dose of 5 mg at Week 3 (W3). From W3 to W18, the treatment is maintained at a 5 mg dose.
Receives: Drug: Phase IIb:Efsubaglutide Alfa 5 mg QW
Phase IIb:Efsubaglutide Alfa 10 mg QWExperimentalThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg, reaching the target dose of 10 mg at Week 5 (W5). From W5 to W18, the treatment is maintained at a 10 mg dose.
Receives: Drug: Phase IIb:Efsubaglutide Alfa 10 mg QW
Phase IIb:Efsubaglutide Alfa 20 mg QWExperimentalThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg at Week 7 (W7). From W7 to W18, the treatment is maintained at a 20 mg dose.
Receives: Drug: Phase IIb:Efsubaglutide Alfa 20 mg QW
Phase IIb:Efsubaglutide Alfa 20 mg Q2WExperimentalFrom Week 1 (W1) to Week 6 (W6), the drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg at Week 7 (W7). From W7 to W18, the drug is administered every two weeks and maintained at a 20 mg dose.
Receives: Drug: Phase IIb:Efsubaglutide Alfa 20 mg Q2W
Phase IIb:PlaceboPlacebo comparatorOnce weekly
Receives: Drug: Phase IIb:Placebo
Phase III:Recommended Phase 3 Dose (RP3D) Low Dose QWExperimentalThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, The dose escalation continues until reaching the RP3D Low Dose, and then the RP3D is maintained. The total cumulative duration of drug administration (from the first dose to the end of maintenance) is 48 weeks, with the once-weekly administration frequency retained throughout the entire period.
Receives: Drug: Phase III:Recommended Phase 3 Dose Low Dose
Phase III:Recommended Phase 3 Dose (RP3D) High Dose QWExperimentalThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, The dose escalation continues until reaching the RP3D High Dose, and then the RP3D is maintained. The total cumulative duration of drug administration (from the first dose to the end of maintenance) is 48 weeks, with the once-weekly administration frequency retained throughout the entire period.
Receives: Drug: Phase III:Recommended Phase 3 Dose High Dose
Phase III:Recommended Phase 3 Dose (RP3D) High Dose Q2WExperimentalThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence: 1 mg → 5 mg → 10 mg → 20 mg. Dose escalation continues until reaching the RP3D High Dose. Once the RP3D High Dose is achieved, the treatment regimen transitions to alternating weekly between RP3D High Dose and placebo for the remainder of the study. The total cumulative duration of drug administration (from the first dose to the end of the maintenance phase) remains 48 weeks, with the once-weekly administration frequency retained throughout. Blinding is maintained across all treatment groups to ensure unbiased evaluation of efficacy and safety.
Receives: Drug: Phase III:Recommended Phase 3 Dose High Dose; Drug: Phase III:Placebo
Phase III:PlaceboPlacebo comparatorOnce weekly
Receives: Drug: Phase III:Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in body weight from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks)

  2. Proportion of subjects with ≥5% reduction in body weight from baseline

    Measured: Phase III (30 weeks)

Secondary outcomes (15)
  1. Proportion of subjects with ≥5% reduction in body weight from baseline

    Measured: Phase IIb (18 weeks) , Phase III (48 weeks)

  2. Proportion of subjects with ≥10%, and ≥15% reduction in body weight from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  3. Percentage change in body weight from baseline

    Measured: Phase III (48 weeks)

  4. Change in body weight from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  5. Change in BMI from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  6. Change in waist circumference from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  7. Change in hip circumference from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  8. Change in blood pressure (diastolic and systolic) from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  9. Change in lipid levels (triglycerides, total cholesterol, low-density lipoprotein cholesterol) from baseline, percentage change from baseline, and ratio to baseline.

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  10. Change in blood glucose levels (FPG) from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  11. Change in blood glucose levels (HbA1c) from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  12. Change in blood glucose levels (fasting insulin) from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  13. Change in blood glucose levels (insulin resistance index [HOMA-IR]) from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  14. Change in blood uric acid levels from baseline

    Measured: Phase IIb (18 weeks) , Phase III (30 weeks and 48 weeks)

  15. Change in IWQOL-lite-CT (Impact of Weight on Quality of Life-Lite-Clinical Trial Version) Questionnaire Score from Baseline

    Measured: Phase III (30 weeks and 48 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2025
  2. Study start31 Mar 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,003 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06921486
Sponsor's protocol ID
YN011-W303
Other IDs
YN011-W202, YN011-W303
Status last verified
Jan 2026
First submitted
28 Mar 2025
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Phase IIb:Efsubaglutide Alfa 5 mg QW, Phase IIb:Efsubaglutide Alfa 10 mg QW and Phase IIb:Efsubaglutide Alfa 20 mg QW in people with Obesity and Overweight, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 41 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 29 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 combined 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.

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?

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?

Percentage change in body weight from baseline (time frame: Phase IIb (18 weeks) , Phase III (30 weeks)). 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 Jan 2026.

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