Diabetes Mellitus, Type 2Phase 1NCT03789578
A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together
A Phase 1 study testing NNC0148-0287sema, Semaglutide and NNC0148-0287 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NNC0148-0287sema, Semaglutide and NNC0148-0287
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jan 2019to 10 Oct 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening
- Body weight between 80.0 to 120.0 kg (both inclusive)
- Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
- No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
- Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) Any metformin formulation (dose as documented in the subject medical record), b) One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor
Who cannot join
- Known or suspected hypersensitivity to trial products or related products
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
- Receipt of any investigational medicinal product within 90 days before screening
- History of severe allergies to drugs or foods or a history of severe anaphylactic reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes
The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 32 weeks in total.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0148-0287sema, Semaglutide, NNC0148-0287
- 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.
NNC0148-0287semaDrug
Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.
SemaglutideDrug
Also called Ozempic®
Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
NNC0148-0287Drug
Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide plus insulin 287 | Experimental | Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)). Receives: Drug: NNC0148-0287sema |
| Semaglutide alone | Experimental | Participants will get a single dose of semaglutide (treatment B) alone. Receives: Drug: Semaglutide |
| Insulin 287 alone | Experimental | Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone. Receives: Drug: NNC0148-0287 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Measured: 0-840 hours
AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Measured: 0-840 hours
Secondary outcomes (20)
AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose
Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Measured: 0-840 hours
Cmax, I287, maximum observed serum insulin 287 concentration after a single dose
Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Measured: 0-840 hours
tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose
Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Measured: 0-840 hours
AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose
Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Measured: 0-840 hours
Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose
Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Measured: 0-840 hours
tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose
Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Measured: 0-840 hours
Number of treatment emergent adverse events
Count of events.
Measured: Day 1 (beginning of each period) to day 36 (end of each period)
Number of hypoglycaemic episodes
Count of episodes.
Measured: Day 1 (beginning of each period) to day 36 (end of each period)
Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels
Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287.
Measured: Day -1 (pre-dose), Day 36 (end of period)
Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies
Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
Measured: Day 36 (end of period)
Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
Measured: Day 36 (end of period)
Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels
Measured as percentage B/T following administration of NNC0148 -0287sema
Measured: Day -1 (pre-dose), Day 36 (end of period)
Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies
Percentage of events (yes/no) following administration of NNC0148 -0287sema.
Measured: Day 36 (end of period)
Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)
Percentage of events (yes/no) following administration of NNC0148 -0287sema.
Measured: Day 36 (end of period)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels
Measured as percentage B/T.
Measured: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1
Percentage of events (yes/no).
Measured: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels
Measured as percentage B/T.
Measured: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
Percentage of events (yes/no).
Measured: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies
Percentage of events (yes/no).
Measured: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1
Percentage of events (yes/no).
Measured: Day 151 (follow-up/end-of-trial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start17 Jan 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789578
- Sponsor's protocol ID
- NN1535-4359
- Other IDs
- U1111-1204-8233, 2017-004538-27, 2017
- Status last verified
- Nov 2024
- First submitted
- 27 Dec 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Westergaard L, Alifrangis L, Buckley ST, Coester HV, Klitgaard T, Kristensen NR, Nishimura E, Norgreen L, Rocha TMP, Steensgaard DB, Vegge A, Plum-Morschel L. Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2024 Nov;44(11):849-861. doi: 10.1007/s40261-024-01405-8. Epub 2024 Nov 3.
PubMed 39488821
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03789578
- Acronym / sponsor ID
- NN1535-4359
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 32 weeks in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide plus insulin 287 | Experimental | Drug: NNC0148-0287semaParticipants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)). |
| Semaglutide alone | Experimental | Drug: SemaglutideParticipants will get a single dose of semaglutide (treatment B) alone. |
| Insulin 287 alone | Experimental | Drug: NNC0148-0287Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening
- Body weight between 80.0 to 120.0 kg (both inclusive)
- Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
- No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
Key exclusion criteria (5 listed)
- Known or suspected hypersensitivity to trial products or related products
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
- Receipt of any investigational medicinal product within 90 days before screening
- History of severe allergies to drugs or foods or a history of severe anaphylactic reaction
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 |
|---|---|---|
| NNC0148-0287semaStudy staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen. | Drug | Semaglutide plus insulin 287 |
| SemaglutideAlso: Ozempic®Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen. | Drug | Semaglutide alone |
| NNC0148-0287Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen. | Drug | Insulin 287 alone |
Primary outcome
AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
Time frame: 0-840 hours
Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
Time frame: 0-840 hours
Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
20 secondary outcomes
AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose
Time frame: 0-840 hours
Cmax, I287, maximum observed serum insulin 287 concentration after a single dose
Time frame: 0-840 hours
tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose
Time frame: 0-840 hours
AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose
Time frame: 0-840 hours
Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose
Time frame: 0-840 hours
tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose
Time frame: 0-840 hours
Number of treatment emergent adverse events
Time frame: Day 1 (beginning of each period) to day 36 (end of each period)
Number of hypoglycaemic episodes
Time frame: Day 1 (beginning of each period) to day 36 (end of each period)
Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels
Time frame: Day -1 (pre-dose), Day 36 (end of period)
Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies
Time frame: Day 36 (end of period)
Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
Time frame: Day 36 (end of period)
Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels
Time frame: Day -1 (pre-dose), Day 36 (end of period)
Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies
Time frame: Day 36 (end of period)
Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)
Time frame: Day 36 (end of period)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels
Time frame: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1
Time frame: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels
Time frame: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
Time frame: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies
Time frame: Day 151 (follow-up/end-of-trial visit)
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1
Time frame: Day 151 (follow-up/end-of-trial visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 39488821Westergaard L, Alifrangis L, Buckley ST, Coester HV, Klitgaard T, Kristensen NR, Nishimura E, Norgreen L, Rocha TMP, Steensgaard DB, Vegge A, Plum-Morschel L. Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2024 Nov;44(11):849-861. doi: 10.1007/s40261-024-01405-8. Epub 2024 Nov 3.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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 Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0148-0287sema, Semaglutide and NNC0148-0287 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. 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 Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose (time frame: 0-840 hours). 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?
On the ClinicalTrials.gov record for NCT03789578, 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 12 Nov 2024.