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Type 2 Diabetes MellitusPhase 1XW003NCT04389775

To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants

A Phase 1 study testing Cohort A and Cohort B in people with Type 2 Diabetes Mellitus and Obesity, run by Sciwind Biosciences APAC CO Pty. Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

XW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management. This is a first-in-human (FIH), single-centre, double blind, randomised, SAD and MAD study of XW003 conducted in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Cohort A and Cohort B
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteAustralia
Study dates
29 Mar 2020to 29 Sep 2021
Phase
Phase 1
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Single Dose Cohort-Inclusion Criteria:

  1. Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consent);
  2. Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
  3. Participants must have a BMI greater than or equal to 20.0 kg/m2 and less than or equal to 35.0 kg/m2 and weigh greater than or equal to 50 kg but less than or equal to 90 kg at Screening;
  4. Stable body weight for at least three (3) months prior to Screening (i.e., <5% change);
  5. Participants must have A1c below 6.4%, FPG: 3.9 ~ 6.1 mmol/L (both inclusive) or 70~110 mg/dL (both inclusive). All other clinical laboratory values must be within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate;
  6. Non-smoker and/or casual smoker who uses no more than 10 cigarettes (or equivalent quantity of any other nicotine containing products e.g., cigars, chewing tobacco, snuff, etc.) per week. Participants must abstain from smoking 5 days prior to admission and throughout the confinement period, and test negative on Day -1 for urine cotinine test. Participants must also abstain from smoking 72 hours prior to each outpatient visit;
  7. Participants must agree to abstain from alcohol intake from 48 hours prior to admission and during the confinement period;
  8. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion, including the follow up period.
  9. Males must not donate sperm for at least 90 days after the last dose of study drug;
  10. Participants must have the ability and willingness to attend the necessary visits to the CRU;
  11. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Single Dose Cohort-Exclusion Criteria:

  1. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments;
  2. Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
  3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
  4. History of acute or chronic pancreatitis;
  5. Participants must be willing not to undertake any strenuous exercise, including but not limited to weightlifting (greater than 5 times per week) within 5 days prior to first study drug administration and for the duration of the study (including the follow-up period);
  6. Participants must not start or having started participation in any medical (e.g., assisted by a clinical dietician or nutritionist) or non-medical (e.g., by a gym coach) diet and/or exercise programme within 3 months prior to Screening and for the duration of the study (including the follow-up period);
  7. Use and/or planned use of any approved or unapproved weight-lowering medication(s) (including but not limited to orlistat, sibutramine, rimonabant, phentermine, or liraglutide) and/or medical device(s) within 3 months prior to Screening and for the duration of the study (including the follow-up period);
  8. Previous history of any major gastrointestinal (including hepatobiliary and/or pancreatic) surgeries, including but not limited to sleeve, subtotal, or total gastrectomy, gastrojejunostomy, gastroduodenectomy, gastroduodenostomy, jejunectomy, ileectomy (proto)colectomy, hepatectomy, and pancreatectomy (except for appendectomy or cholecystectomy) and planned performance of one or more of the above mentioned for the duration of the study (including the follow-up period);
  9. History of cerebral stroke (including but not limited to cerebral infarction/hemorrhage) within 12 months prior to Screening;
  10. History of acute coronary syndrome (angina pectoris/myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia[s]) within 12 months prior to Screening;
  11. Systolic blood pressure (BP) greater than 140 mmHg and/or less than 90 mmHg and/or diastolic BP greater than 90 mmHg and/or less than 40 mmHg and/or pulse rate greater 100 bpm and/or less than 40 bpm at Screening with one repeat allowed per by the Investigator or delegate at Screening and/or on Admission
  12. Any clinically significant arrhythmia(s) at Screening ECG; specifically, the participant's corrected QT interval (QTcF) (Fridericia's correction) is greater than 450 ms at Screening and on Day -1. An out-of-range or abnormal ECG may be repeated during Screening. On admission, three ECGs should be recorded consecutively, and the Investigator must evaluate the triplicate ECG. If the participant's QTcF is greater than 450 ms on at least two ECGs, the participant must be excluded;
  13. Any medically uncontrolled respiratory disease(s) and/or condition(s), including but not limited to severe current asthma, chronic obstructive pulmonary disease, and obstructive sleep apnoea syndrome;
  14. Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening;
  15. Clinically significant gastrointestinal disease(s), including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastroparesis, and diabetic diarrhoea;
  16. With alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) greater than 1.5 × upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate;
  17. With a confirmed creatinine clearance (CLcr) using the Cockcroft-Gault equation below 90 mL/min. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate;
  18. History of clinically significant endocrine condition(s), including but not limited to hyper/hypothyroidism and/or hyper/hypoadrenalism;
  19. History of primary or recurrent malignancy, except for non-melanoma skin cancer excised more than 2 years prior to Screening and/or cervical intraepithelial neoplasia having been successfully cured more than 5 years prior to Screening;
  20. With clinically significant haematologic abnormalities, including but not limited to haemoglobin above 180 g/L and/or below 110 g/L, white blood cell count (WBC) above 10.5×10^9/L and/or below 3.5×10^9/L, absolute neutrophil count above 7.0×10^9/L and/or below 2.0×10^9/L, and/or platelet count above 300×10^9/L and/or below 130×10^9/L. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate;
  21. With any other clinically significant laboratory abnormalities in clinical biochemistry, coagulation function, and/or urinalysis. Repeat testing at Screening is acceptable for out of range values following approval by the Investigator or delegate;
  22. With positive test result(s) for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening;
  23. History of life-threatening infection (e.g. meningitis) and/or any major infections requiring parental antimicrobials within 6 months prior to Screening;
  24. Regular alcohol consumption (by self-declaration) defined as greater than 21 alcohol units per week (where 1 unit = 284-mL of beer, 25-mL of 40% spirit or a 125-mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and during the confinement period;
  25. With a history of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years (by self-declaration);with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, methamphetamines, methylenedioxy-methamphetamine [MDMA], phencyclidine, benzodiazepines, opiates and cocaine), or alcohol breath test;
  26. History of severe allergic or anaphylactic reactions;
  27. Known or suspected intolerance or hypersensitivity to the IP, close related compounds, or any of the stated ingredients;
  28. Blood donation or significant blood loss (greater than or equal to 400 mL) within 60 days prior to the first study drug administration;
  29. Plasma donation within 7 days prior to the first study drug administration;
  30. Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study and for at least 3 months after the last dose of study drug;
  31. Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half lives of the product (whichever is the longest) or participation in more than four investigational drug studies within 1 year prior to Screening;
  32. Previous treatment with glucagon-like peptide 1 (GLP-1) agonists within the last 3 months;
  33. Use of any prescription drug(s) and medical device(s) (other than hormonal contraception: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD) within 2 weeks prior to the first study drug dosing or use of any over the-counter (OTC) medication, herbal remedies, supplements or vitamins within 1 week prior to the first study drug dosing and during the course of the study without prior approval of the Investigator and MM. Use of simple analgesic(s) (e.g., paracetamol, a nonsteroidal anti-inflammatory drug [NSAID]) may be permitted at the discretion of the Investigator;
  34. Present comedication with drugs known to interfere with glucose metabolism, such as systemic corticosteroids, non-selective beta-blockers, and monoamine oxidase inhibitors;
  35. Presence of any underlying physical and/or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with the protocol or complete the study per protocol.

Repeat Dose Cohort - Inclusion Criteria

To be eligible for this study, participants must meet all of the following additional inclusion criteria:

  1. Participants must have a Body Mass Index (BMI) ≥24.0 kg/m2 and ≤34.0 kg/m2 and a Body weight ≥70 kg;
  2. Participants must be willing to test and document glucose at home using a glucometer;

Repeat Dose Cohort - Exclusion Criteria:

A participant who meets any of the following additional exclusion criteria must be excluded from the study:

  1. Obesity induced by endocrine disorders (e.g., Cushing Syndrome);
  2. Any clinical laboratory values deviating from or outside the laboratory reference range unless considered not to be clinically significant by the Investigator or delegate;
  3. History of thyroid tumors of family history of thyroid tumors.
  4. Hemoglobin, white cell count, neutrophil count, and platelet count must fall within the laboratory's normal ranges. Any other hematological parameters outside the normal range may be acceptable if clinically insignificant and at the Investigator's discretion. Repeat testing at Screening is acceptable following approval by the Investigator or delegate;

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Nucleus Network Pty Ltd

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XW003 Injection in Healthy Adult Participants

XW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management. This is a first-in-human (FIH), single-centre, double blind, randomised, SAD and MAD study of XW003 conducted in healthy adult participants. The study is designed to evaluate the safety, tolerability, PK, and PD of XW003 in healthy adult participants.

Read the detailed description

Participants will undergo a Screening period beginning up to 28 days prior to randomisation/dose administration. Participants will undergo pre-dose assessments, post-dose assessments, and will complete an EOS follow-up visit or early termination (ET) visit.

Up to 42 participants will be enrolled into one of up to six (6) sequential cohorts (Cohorts A1 to A6). Participants in each cohort will be randomised to receive a single subcutaneous (SC) dose of either XW003 or matching placebo on Day 1 following an overnight fast. Two sentinel participants will receive a single SC dose of XW003 initially. If dosing of these sentinel participants proceeds without clinically significant safety signals in the first 48 hours post-dose, the remaining participants will receive a single dose of XW003 or placebo according to the randomisation schedule.

Participants in Cohorts B1 to B3 (n=10 per cohort) will be randomized to receive a single SC dose of either XW003 (n=8) or matching placebo (n=2) once weekly for 6 weeks. Doses will be administered following an overnight fast of at least 10 hours.

Being tested
Cohort A, Placebo A, Cohort B, Placebo B
Keywords
Type 2 Diabetes Mellitus, Obesity, Nonalcoholic Steatohepatitis
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Non-alcoholic Fatty Liver Disease

What participants receive

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

  • Cohort ADrug

    Also called GLP-1 analogue

    Participants in each cohort (A1 to A6) will be randomised to receive a SC dose of XW003 on Day 1 after overnight fasting by body weight range:

    1. Proposed XW003 Dose Levels (50 kg-75 kg): 0.03mg, 0.1mg, 0.2mg, 0.4mg, 0.8mg and 0.6mg respectively for Cohorts A1 to A6.
    2. Proposed XW003 Dose Levels (76 kg-90 kg): 0.03mg, 0.1mg, 0.25mg, 0.5mg, 1.0 mg and 0.6mg.

    These doses are subject to change following SRC review of each cohort - XW003 dose level will not exceed 2.0 mg.

  • Placebo ADrug

    Also called Placebo

    Participants in each cohort (A1 to A6) will be randomised to receive a SC dose of volume-matching placebo on Day 1 after overnight fasting by body weight range:

    1. Proposed Placebo Dose Levels (50 kg-75 kg): 0.03mg, 0.1mg, 0.2mg, 0.4mg, 0.8mg, and 0.6mg respectively for Cohorts A1 to A6.
    2. Proposed Placebo Dose Levels (76 kg-90 kg): 0.03mg, 0.1mg, 0.25mg, 0.5mg, 1.0 mg and 0.6mg.

    These doses are subject to change following SRC review of each cohort - dose level will not exceed 2.0 mg.

  • Cohort BDrug

    Also called GLP-1 analogue

    Participants in cohorts B1 to B3 (n=10 per cohort) will receive multiple SC doses of XW003 (n=8) once weekly for 6 weeks following an overnight fast of at least 10 hours.

    1. Subject to change following SRC review of each cohort.
    2. Following 4 weeks of once weekly dosing, the SRC will review the safety data (and PK data for Cohort B1 only) to determine the treatment for the following cohort and whether dosing can commence in parallel.
    3. At least 3 days prior to Cohort B3 Week 3 (i.e., 3 days prior to the third dose in Cohort B3), the SRC will review the safety and PK data for Cohorts B1 and B2 to determine whether Cohort 3 dosing for Weeks 3 to 6 may commence.
  • Placebo BDrug

    Also called Placebo

    Participants in cohorts B1 to B3 (n=10 per cohort) will receive multiple SC doses of matching placebo (n=2) once weekly for 6 weeks following an overnight fast of at least 10 hours.

    1. Subject to change following SRC review of each cohort.
    2. Following 4 weeks of once weekly dosing, the SRC will review the safety data (and PK data for Cohort B1 only) to determine the treatment for the following cohort and whether dosing can commence in parallel.
    3. At least 3 days prior to Cohort B3 Week 3 (i.e., 3 days prior to the third dose in Cohort B3), the SRC will review the safety and PK data for Cohorts B1 and B2 to determine whether Cohort 3 dosing for Weeks 3 to 6 may commence.
Study groups in NCT04389775
Study groupRoleWhat they receive
Cohort AExperimentalSubcutaneously administer a single dose of XW003, ranging from 0.03mg to 1.0mg, every cohort by the body weight.
Receives: Drug: Cohort A
Placebo APlacebo comparatorSubcutaneously administer a single dose of volume-matching placebo, ranging from 0.03mg to 1.0mg, every cohort by the body weight.
Receives: Drug: Placebo A
Cohort BExperimentalSubcutaneously administer multiple SC doses of XW003, ranging from 0.2mg to 0.6mg, once weekly for 6 weeks.
Receives: Drug: Cohort B
Placebo BPlacebo comparatorSubcutaneously administer multiple SC doses of volume-matching placebo, ranging from 0.2mg to 0.6mg, once weekly for 6 weeks.
Receives: Drug: Placebo B

What is being measured

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

  1. Number of treatment emergent adverse events (TEAEs)

    Count of adverse events

    Measured: From administration of XW003 on Day 1 to the last follow-up visit

Secondary outcomes (24)
  1. Maximum observed XW003 plasma concentration

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  2. Time of the maximum observed XW003 plasma concentration

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  3. Area under the XW003 plasma concentration-time curve

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  4. Apparent terminal half-life of XW003

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  5. Apparent terminal elimination rate constant of XW003

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  6. Apparent total clearance of XW003

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  7. Apparent volume of distribution of XW003

    Calculated based on XW003 measured in blood.

    Measured: 36 days

  8. Change from Baseline in body weight

    Percentage of body weight loss

    Measured: Day 36 for Cohort A and Day 71 for Cohort B

  9. Change from Baseline in fasting plasma glucose

    Percentage of fasting plasma glucose change

    Measured: Day 36 for Cohort A and Day 71 for Cohort B

  10. Change from Baseline in plasma insulin and pro-insulin

    Percentage of plasma insulin and pro-insulin change

    Measured: Day 36 for Cohort A and Day 71 for Cohort B

  11. Change from Baseline in plasma C-peptide

    Percentage of plasma C-peptide change

    Measured: Day 36 for Cohort A and Day 71 for Cohort B

  12. Change from Baseline in plasma glucagon

    Percentage of plasma glucagon change

    Measured: Day 36 for Cohort A and Day 71 for Cohort B

  13. Change from Baseline in plasma lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL])

    Percentage of plasma lipids (triglyceride, low-density lipoprotein [LDL], and high-density lipoprotein [HDL]) change

    Measured: Day 36 for Cohort A and Day 71 for Cohort B

  14. Incidence of anti-XW003 antibodies at end of study

    Count of episodes

    Measured: Pre-dose of XW003 on Day 1, end of study visit on Day 36 for Cohort A and Day 71 for Cohort B

  15. Area under the plasma concentration curve time zero to the last detectable time point before second dose

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  16. Area under the plasma concentration curve over a dosing interval after first dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  17. Maximum plasma concentration after first dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  18. Time to maximum plasma concentration after first dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  19. Terminal phase elimination rate-constant after first dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  20. Terminal phase elimination half-life after first dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  21. Clearance after last dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  22. Volume of distribution after last dosing

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  23. AUC accumulation ratio constant

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

  24. Trough plasma XW003 concentrations before next dosing (Day 1 to last dosing)

    Calculated based on XW003 measured in blood in repeat dose cohorts

    Measured: 71 days

Timeline

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

  1. First posted15 May 2020
  2. Study start29 Mar 2020
  3. Primary completion29 Sep 2021
  4. Study completion29 Sep 2021

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
One of up to six (6) sequential cohorts (Cohorts A1 to A6). Participants in each cohort will be randomised to receive a single subcutaneous (SC) dose of either XW003 or matching placebo on Day 1 following an overnight fast. Two sentinel participants will receive a single SC dose of XW003 initially. If dosing of these sentinel participants proceeds without clinically significant safety signals in the first 48 hours post-dose, the remaining participants will receive a single dose of XW003 or placebo according to the randomisation schedule. Participants in Cohorts B1 to B3 (n=10 per cohort) will be randomized to receive a single SC dose of either XW003 (n=8) or matching placebo (n=2) once weekly for 6 weeks. Doses will be administered following an overnight fast of at least 10 hours.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389775
Sponsor's protocol ID
SCW0502-1011/1012
Other IDs
ACTRN12620000344998
Acronym
XW003
Status last verified
Oct 2021
First submitted
24 Mar 2020
Last updated
28 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo W, Xu Z, Zou H, Li F, Li Y, Feng J, Zhu Z, Zheng Q, Zhu R, Wang B, Li Y, Hao S, Qin H, Jones CL, Adegbite E, Telusca L, Fenaux M, Zhong W, Junaidi MK, Xu S, Pan H. Discovery of ecnoglutide - A novel, long-acting, cAMP-biased glucagon-like peptide-1 (GLP-1) analog. Mol Metab. 2023 Sep;75:101762. doi: 10.1016/j.molmet.2023.101762. Epub 2023 Jun 24.

    PubMed 37364710

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cohort A and Cohort B in people with Type 2 Diabetes Mellitus and Obesity, run by Sciwind Biosciences APAC CO Pty. Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 28 Oct 2021. 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 Australia. 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?

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?

Number of treatment emergent adverse events (TEAEs) (time frame: From administration of XW003 on Day 1 to the last follow-up visit). 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 NCT04389775, 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 28 Oct 2021.

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