Type 2 Diabetes MellitusPhase 3AMPLITUDE-LNCT03713684

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

A Phase 3 study testing Efpeglenatide SAR439977 and Background therapy in people with Type 2 Diabetes Mellitus, run by Sanofi at 47 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Efpeglenatide SAR439977 and Background therapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 370 participants
Where: 47 sitesin 3 countries
Study dates: 9 Nov 2018to 4 Jan 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participant must be greater than or equal to (>=)18 years of age at the time of signing the informed consent.
Participants with T2DM.
Diabetes diagnosed at least 1 year before screening.
Participants on basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening.
HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening.

Who cannot join

History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.
Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery.
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease requiring medical treatment within 6 months prior to screening.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
Body weight change of >=5 kilograms within the last 3 months prior to screening.

Show all 16Show fewer

Systolic blood pressure greater than (>)180 millimetres of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization.
End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m^2.
Laboratory findings at the screening Visit:
Alanine aminotransferase or aspartate aminotransferase >3 * upper limit of normal (ULN) or total bilirubin >1.5*ULN (except in case of documented Gilbert's syndrome);
Amylase and/or lipase: >3*ULN;
Calcitonin >=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter [pg/mL]).
Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to screening, or planned during study period.
Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women.
Women of childbearing potential not willing to use highly effective method(s) of birth control or who were unwilling to be tested for pregnancy during the study period and for at least 5 weeks after the last dose of study intervention.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

47 sites in 3 countries.

Country

City, postcode or hospital

47 sites in 3 countries

United States22 sites

Investigational Site Number 8400038
Birmingham, Alabama, 35211
Investigational Site Number 8400001
Bridgeton, New Jersey, 08302
Investigational Site Number 8400035
Chandler, Arizona, 85224
Investigational Site Number 8400030
Dallas, Texas, 75230
Investigational Site Number 8400063
Dallas, Texas, 75390-9302
Investigational Site Number 8400005
Glendale, Arizona, 85306
Investigational Site Number 8400057
Huntington Park, California, 90255
Investigational Site Number 8400058
La Jolla, California, 92037
Investigational Site Number 8400025
Lawrenceville, Georgia, 30044
Investigational Site Number 8400037
Layton, Utah, 84041
Investigational Site Number 8400044
Lexington, Kentucky, 40503
Investigational Site Number 8400009
Los Angeles, California, 90057
Investigational Site Number 8400013
Maumee, Ohio, 43537
Investigational Site Number 8400036
Morehead City, North Carolina, 28557
Investigational Site Number 8400039
New Windsor, New York, 12553
Investigational Site Number 8400055
Orlando, Florida, 32825
Investigational Site Number 8400041
Pembroke Pines, Florida, 33026
Investigational Site Number 8400043
San Antonio, Texas, 78229
Investigational Site Number 8400045
Spring Valley, California, 91978
Investigational Site Number 8400040
Tustin, California, 92780
Investigational Site Number 8400026
Van Nuys, California, 91405
Investigational Site Number 8400052
West Des Moines, Iowa, 50265

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South Korea16 sites

Investigational Site Number 4100009
Busan, 49241
Investigational Site Number 4100001
Daejeon, 35233
Investigational Site Number 4100016
Gwangju, 501757
Investigational Site Number 4100010
Gwangju, 61453
Investigational Site Number 4100013
Gyeonggi-do, 11765
Investigational Site Number 4100015
Incheon, 21565
Investigational Site Number 4100014
Jeonju, 54907
Investigational Site Number 4100007
Seongnam-si, 13620
Investigational Site Number 4100008
Seoul, 02447
Investigational Site Number 4100002
Seoul, 03080
Investigational Site Number 4100005
Seoul, 03722
Investigational Site Number 4100004
Seoul, 05278
Investigational Site Number 4100003
Seoul, 06351
Investigational Site Number 4100011
Seoul, 07345
Investigational Site Number 4100006
Seoul, 14647
Investigational Site Number 4100012
Suwon, 16247

Other trials in South Korea

China9 sites

Investigational Site Number 1560005
Baotou, 014010
Investigational Site Number 1560017
Beijing, 100730
Investigational Site Number 1560006
Changsha, 410013
Investigational Site Number 1560001
Chengdu, 610083
Investigational Site Number 1560004
Shanghai, 014010
Investigational Site Number 1560036
Shanghai, 200032
Investigational Site Number 1560012
Shanghai, 200040
Investigational Site Number 1560013
Shanghai, 200040
Investigational Site Number 1560003
Zhengzhou, 450003

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About this study

Official title: A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs).

Secondary Objectives:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control.
To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight.
To evaluate the safety of once weekly injection of efpeglenatide.

Read the detailed description

Study duration per participant was approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.

Conditions: Type 2 Diabetes Mellitus
Being tested: Efpeglenatide SAR439977, Placebo, Background therapy
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.

Efpeglenatide SAR439977Drug
Pharmaceutical form: solution for injection Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Background therapyDrug
Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling.

Study groups in NCT03713684
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs). Receives: Drug: Placebo; Drug: Background therapy
Efpeglenatide 2 mg	Experimental	Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Receives: Drug: Efpeglenatide SAR439977; Drug: Background therapy
Efpeglenatide 4 mg	Experimental	Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56. Receives: Drug: Efpeglenatide SAR439977; Drug: Background therapy
Efpeglenatide 6 mg	Experimental	Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56. Receives: Drug: Efpeglenatide SAR439977; Drug: Background therapy

What is being measured

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

Change From Baseline to Week 30 in HbA1c
Measured: Baseline to Week 30

Secondary outcomes (6)

Number of Participants With HbA1c <7.0% at Week 30
Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.
Measured: Week 30
Change From Baseline to Week 56 in HbA1c
This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.
Measured: Baseline to Week 56
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
Measured: Baseline to Week 30
Change From Baseline to Week 30 and Week 56 in Body Weight
This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.
Measured: Baseline to Week 30 and Week 56
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia)
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Baseline up to Week 56
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Baseline up to Week 56

Timeline

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

9 Nov 20184 Jan 2021

First posted22 Oct 2018
Study start9 Nov 2018
Primary completion20 Nov 2020
Study completion4 Jan 2021

Why it stopped: Sponsor decision to cancel TRIAL, not related to safety concern

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03713684
Sponsor's protocol ID: EFC14893
Other IDs: U1111-1189-5009
Acronym: AMPLITUDE-L
Status last verified: Nov 2021
First submitted: 18 Oct 2018
Last updated: 2 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
ClinicalTrials.gov ID: NCT03713684
Acronym / sponsor ID: AMPLITUDE-L / EFC14893
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision to cancel TRIAL, not related to safety concern
Enrolment: 370 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Collaborators: Hanmi Pharmaceutical Company Limited
Study start: 9 Nov 2018 (actual)
Primary completion: 20 Nov 2020 (actual)
Study completion: 4 Jan 2021 (actual)
First posted: 22 Oct 2018 (actual)
Results: Posted 2 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

Secondary Objectives:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control.
To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight.
To evaluate the safety of once weekly injection of efpeglenatide.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: Background therapyParticipants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).
Efpeglenatide 2 mg	Experimental	Drug: Efpeglenatide SAR439977, Drug: Background therapyParticipants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
Efpeglenatide 4 mg	Experimental	Drug: Efpeglenatide SAR439977, Drug: Background therapyParticipants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
Efpeglenatide 6 mg	Experimental	Drug: Efpeglenatide SAR439977, Drug: Background therapyParticipants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant must be greater than or equal to (>=)18 years of age at the time of signing the informed consent.
Participants with T2DM.
Diabetes diagnosed at least 1 year before screening.
Participants on basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening.
HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening.

Key exclusion criteria (16 listed)

History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.
Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery.
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease requiring medical treatment within 6 months prior to screening.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).

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
Efpeglenatide SAR439977Pharmaceutical form: solution for injection Route of administration: subcutaneous	Drug	Efpeglenatide 2 mg, Efpeglenatide 4 mg, Efpeglenatide 6 mg
PlaceboPharmaceutical form: solution for injection Route of administration: subcutaneous	Drug	Placebo
Background therapyLantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling.	Drug	Efpeglenatide 2 mg, Efpeglenatide 4 mg, Efpeglenatide 6 mg, Placebo

Primary outcome

Change From Baseline to Week 30 in HbA1c
Time frame: Baseline to Week 30

6 secondary outcomes

Number of Participants With HbA1c <7.0% at Week 30
Time frame: Week 30
Change From Baseline to Week 56 in HbA1c
Time frame: Baseline to Week 56
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 30
Change From Baseline to Week 30 and Week 56 in Body Weight
Time frame: Baseline to Week 30 and Week 56
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia)
Time frame: Baseline up to Week 56
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
Time frame: Baseline up to Week 56

Results and safety

Results posted to the registry on 2 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	92	6
Efpeglenatide 2 mg	92	5
Efpeglenatide 4 mg	93	5
Efpeglenatide 6 mg	93	6

Primary outcome: Change From Baseline to Week 30 in HbA1c

Time frame: Baseline to Week 30. Mean (Standard Deviation). Unit: percentage of HbA1c

Measure	Placebo n = 59	Efpeglenatide 2 mg n = 63	Efpeglenatide 4 mg n = 60	Efpeglenatide 6 mg n = 63
Value	-0.33 (1.09)	-1.27 (0.95)	-1.24 (0.96)	-1.43 (0.94)

Population analysed: Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization. Here, "Overall number of participants analyzed"= participants evaluable for this outcome measure.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	9 of 92 (9.8%)	25 of 92 (27.2%)	0 of 92
Efpeglenatide 2 mg	7 of 92 (7.6%)	33 of 92 (35.9%)	0 of 92
Efpeglenatide 4 mg	5 of 96 (5.2%)	42 of 96 (43.8%)	0 of 96
Efpeglenatide 6 mg	10 of 90 (11.1%)	46 of 90 (51.1%)	0 of 90

Limitations and caveats (from the sponsor): The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, few efficacy evaluations originally planned in the protocol were no longer considered to be relevant and were not performed. Primary, and secondary efficacy data were descriptively summarized and data were carefully considered given that the study was terminated early.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.

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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.

Clinical Sciences & Operations study director

Sanofi

47 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efpeglenatide SAR439977 and Background therapy in people with Type 2 Diabetes Mellitus, run by Sanofi at 47 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, South Korea, 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 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?

Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 to Week 30 in HbA1c (time frame: Baseline to Week 30). 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 NCT03713684.

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 2 Dec 2021.