Neisseria GonorrheaPhase 1LTBNG601NCT07758972
Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine
A Phase 1 study testing LTB-NG6 and Sodium Chloride 0.9% in people with Neisseria Gonorrhea, run by LimmaTech Biologics AG at 1 site in Germany.
Trial summary
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrhea
- What is being tested?
- LTB-NG6 and Sodium Chloride 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2026to 23 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-50 years (inclusive) at the time of the first injection
- Good and stable general health, determined by medical history, laboratory findings and physical examination as judged by the Investigator before receiving the first injection.
- Willingness and ability to comply with the requirements of the protocol (e.g., completion of the diary forms, return for follow-up visits)
- Signed written informed consent obtained
- Availability for the trial duration, including all planned follow-up visits and phone calls
- Negative urine pregnancy test for WOCBP. WOCBP must be willing to use a highly effective method of contraception during the trial
Who cannot join
- Health conditions that, in the opinion of the Investigator, may interfere with optimal participation in the trial or place the participant at increased risk of adverse events
- Acute or active infectious disease (including symptomatic sexually transmitted infections or any other ongoing acute infections), fever (oral temperature ≥38.0°C), or acute illness at the time of enrollment.
- History of gonorrhea at any time (either self-reported or medically confirmed) or confirmed at screening by a positive nucleic acid amplification test (NAAT) result for Neisseria gonorrhoeae
- History of prior confirmed N. meningitidis infection
- Previous vaccination with Bexsero or any meningococcal serogroup B vaccine (including self-report)
- Any deviation from the normal range in biochemistry or hematology blood tests clinically significant in the opinion of the Investigator, measured at the screening visit
Show all 21Show fewer
- Clinical conditions representing contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder)
- Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder)
- Positive test for active HBV infection (positive HBsAG test), any HCV infection (positive HCV antibody test), or any HIV-1/2 infection
- Planned or actual administration of any licensed vaccine within 14 days prior to enrollment. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by the public health authorities, the time period described above can be reduced, if necessary, for that vaccine, provided that it is licensed or authorized and that it is used according to the local governmental recommendations, and provided that a written approval from the Sponsor is obtained
- Body Mass Index (BMI) ≤19 or ≥35
- History of systemic administration of corticosteroids (PO/IV/IM) within the last month prior to injection or for more than 14 consecutive days within 3 months prior to injection (i.e., prednisone or equivalent ≥20 mg/day). Inhaled and topical steroids are allowed
- Administration of antineoplastic, immune-modulating, immunosuppressive agents or chemotherapy within 3 months prior to injection
- Suspected or known hypersensitivity (including allergy) to any of the vaccine components or medical equipment whose use is foreseen in this trial
- Concurrently participating in another clinical trial or planned participation at any time during the trial period, in which the participant has been or will be exposed to an investigational or a non-investigational interventional vaccine/product (pharmaceutical product)
- History of any chronic or progressive disease that according to judgment of the Investigator could interfere with the trial outcomes or pose a threat to the participant's health
- Received an investigational or non-registered product (medicinal drug or vaccine), within 3 months prior to enrollment or planned use during the trial period
- Administration of immunoglobulin and/or any blood products within the three months prior to enrollment
- Blood donation equal or greater to 500 mL of blood drawn within 3 months prior to enrollment
- Participants with an elective surgical intervention, planned during the trial period until one month after second injection
- Female participants lactating, pregnant, or intending to become pregnant as reported by the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Nuvisan GmbH
Neu-Ulm, Bavaria, 89231
Steffen Haffner, Dr.
About this study
Official title: A First in Human Phase I Randomized and Controlled Trial to Test Safety and Immunogenicity of a Multivalent Vaccine Against Neisseria Gonorrhoeae
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
Read the detailed description
LTB-NG6 is a vaccine including 6 N. gonorrhoeae antigens. During the study, healthy adults will be randomized to receive 1 of 5 different vaccine doses, or a placebo.
Participants will receive a 2-dose schedule.
- Conditions
- Neisseria Gonorrhea
- Being tested
- LTB-NG6, Sodium Chloride 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTB-NG6Biological
LTB-NG6 administrated at 5 different doses
Sodium Chloride 0.9%Other
sodium chloride 0.9% used as a diluent in LTB-NG6 and as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive 2 administrations of Sodium chloride 0.9% Receives: Other: Sodium Chloride 0.9% |
| Dose 1 | Experimental | Participants receive 2 Dose 1 administrations of the investigational product Receives: Biological: LTB-NG6 |
| Dose 2 | Experimental | Participants receive 2 Dose 2 administrations of the investigational product Receives: Biological: LTB-NG6 |
| Dose 3 | Experimental | Participants receive 2 Dose 3 administrations of the investigational product Receives: Biological: LTB-NG6 |
| Dose 4 | Experimental | Participants receive 2 Dose 4 administrations of the investigational product Receives: Biological: LTB-NG6 |
| Dose 5 | Experimental | Participants receive 2 Dose 5 administrations of the investigational product Receives: Biological: LTB-NG6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: local and systemic AEs (7-days-post)
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose:
- Percentage of participants reporting each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).
Measured: During 7 days following each injection
Safety: any events after each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose:
- Percentage of participants reporting any adverse event (AE) following each injection
- Percentage of participants reporting each severity level (Grade 1-4) of solicited local, systemic and unsolicited AEs following each injection
Measured: During 28 days following each injection
Safety: unsolicited AEs, SAEs, MAAEs
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose:
- Percentage of participants with unsolicited AEs.
- Percentage of participants with serious adverse events (SAEs) following each injection.
- Percentage of participants with medically attended adverse events (MAAEs) following each injection.
Measured: Through study completion, an average of 18 months
Immunogenicity - primary IgGs GMT
To evaluate the immunogenicity of different doses of LTB-NG6 to identify the preferred dose(s). Serum IgG geometric mean titers (GMTs) against each of the N. gonorrhoeae antigens included in LTB-NG6 summarized by treatment group
Measured: At 28 days after the second injection
Secondary outcomes (3)
Immunogenicity - secondary IgGs
To expand the evaluation of the immunogenicity of LTB-NG6 for each treatment group at baseline and 28 days after each injection for each of the antigens included in LTB-NG6:
- Serum IgG GMTs (except for primary endpoint)
- Serum IgG geometric mean fold ratio (GMFR)
- Percentage of participants with ≥ 4-fold increase in serum IgG titer.
Measured: At baseline and 28 days after the second injection
Safety: AEs relatedness to injection, vaccine vs. placebo
To further evaluate the safety of LTB-NG6. Percentage of participants with solicited local, systemic, unsolicited AEs, and SAEs according to relatedness to injection, in vaccinees vs. placebo.
Measured: Through study completion, an average of 18 months
Safety: lab abnormalities
To evaluate changes in hematological and blood chemistry parameters following each injection. Percentage of participants with hematological and blood chemistry laboratory abnormalities at 7 days after each injection compared to baseline in vaccinees vs. placebo.
Measured: At baseline and 7 days after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start19 Aug 2026
- Primary completion26 Apr 2027 (estimated)
- Study completion23 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neisseria GonorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LimmaTech Biologics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nuvisan, Germany, Wellcome Trust, German Federal Ministry of Education and Research, Novo Nordisk Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758972
- Sponsor's protocol ID
- LTBNG601
- Other IDs
- OTA No. 75A50122C00028, 224842/Z/21/Z, Agreement Dated 1/30/23, NNF23SA0088536, 2026-526168-19-00
- Acronym
- LTBNG601
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedges SR, Mayo MS, Mestecky J, Hook EW 3rd, Russell MW. Limited local and systemic antibody responses to Neisseria gonorrhoeae during uncomplicated genital infections. Infect Immun. 1999 Aug;67(8):3937-46. doi: 10.1128/IAI.67.8.3937-3946.1999.
PubMed 10417159Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, Black S. Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study. Lancet. 2017 Sep 30;390(10102):1603-1610. doi: 10.1016/S0140-6736(17)31449-6. Epub 2017 Jul 10.
PubMed 28705462Russell MW, Jerse AE, Gray-Owen SD. Progress Toward a Gonococcal Vaccine: The Way Forward. Front Immunol. 2019 Oct 15;10:2417. doi: 10.3389/fimmu.2019.02417. eCollection 2019.
PubMed 31681305Wi T, Lahra MM, Ndowa F, Bala M, Dillon JR, Ramon-Pardo P, Eremin SR, Bolan G, Unemo M. Antimicrobial resistance in Neisseria gonorrhoeae: Global surveillance and a call for international collaborative action. PLoS Med. 2017 Jul 7;14(7):e1002344. doi: 10.1371/journal.pmed.1002344. eCollection 2017 Jul.
PubMed 28686231Zhu W, Thomas CE, Chen CJ, Van Dam CN, Johnston RE, Davis NL, Sparling PF. Comparison of immune responses to gonococcal PorB delivered as outer membrane vesicles, recombinant protein, or Venezuelan equine encephalitis virus replicon particles. Infect Immun. 2005 Nov;73(11):7558-68. doi: 10.1128/IAI.73.11.7558-7568.2005.
PubMed 16239559Bruxvoort KJ, Lewnard JA, Chen LH, Tseng HF, Chang J, Veltman J, Marrazzo J, Qian L. Prevention of Neisseria gonorrhoeae With Meningococcal B Vaccine: A Matched Cohort Study in Southern California. Clin Infect Dis. 2023 Feb 8;76(3):e1341-e1349. doi: 10.1093/cid/ciac436.
PubMed 35642527Abara WE, Bernstein KT, Lewis FMT, Schillinger JA, Feemster K, Pathela P, Hariri S, Islam A, Eberhart M, Cheng I, Ternier A, Slutsker JS, Mbaeyi S, Madera R, Kirkcaldy RD. Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhoea: a retrospective observational study. Lancet Infect Dis. 2022 Jul;22(7):1021-1029. doi: 10.1016/S1473-3099(21)00812-4. Epub 2022 Apr 12.
PubMed 35427490Belcher T, Rollier CS, Dold C, Ross JDC, MacLennan CA. Immune responses to Neisseria gonorrhoeae and implications for vaccine development. Front Immunol. 2023 Aug 17;14:1248613. doi: 10.3389/fimmu.2023.1248613. eCollection 2023.
PubMed 37662926
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Phase I Randomized and Controlled Trial to Test Safety and Immunogenicity of a Multivalent Vaccine Against Neisseria Gonorrhoeae
- ClinicalTrials.gov ID
- NCT07758972
- Acronym / sponsor ID
- LTBNG601 / LTBNG601
- Conditions
- Neisseria Gonorrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- LimmaTech Biologics AGIndustry (pharma, biotech, devices)
- Collaborators
- Nuvisan, Germany, Wellcome Trust, German Federal Ministry of Education and Research, Novo Nordisk Foundation
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 26 Apr 2027 (estimated)
- Study completion
- 23 Sep 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
Detailed description
LTB-NG6 is a vaccine including 6 N. gonorrhoeae antigens. During the study, healthy adults will be randomized to receive 1 of 5 different vaccine doses, or a placebo.
Participants will receive a 2-dose schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Sodium Chloride 0.9%Participants receive 2 administrations of Sodium chloride 0.9% |
| Dose 1 | Experimental | Biological: LTB-NG6Participants receive 2 Dose 1 administrations of the investigational product |
| Dose 2 | Experimental | Biological: LTB-NG6Participants receive 2 Dose 2 administrations of the investigational product |
| Dose 3 | Experimental | Biological: LTB-NG6Participants receive 2 Dose 3 administrations of the investigational product |
| Dose 4 | Experimental | Biological: LTB-NG6Participants receive 2 Dose 4 administrations of the investigational product |
| Dose 5 | Experimental | Biological: LTB-NG6Participants receive 2 Dose 5 administrations of the investigational product |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-50 years (inclusive) at the time of the first injection
- Good and stable general health, determined by medical history, laboratory findings and physical examination as judged by the Investigator before receiving the first injection.
- Willingness and ability to comply with the requirements of the protocol (e.g., completion of the diary forms, return for follow-up visits)
- Signed written informed consent obtained
- Availability for the trial duration, including all planned follow-up visits and phone calls
Key exclusion criteria (21 listed)
- Health conditions that, in the opinion of the Investigator, may interfere with optimal participation in the trial or place the participant at increased risk of adverse events
- Acute or active infectious disease (including symptomatic sexually transmitted infections or any other ongoing acute infections), fever (oral temperature ≥38.0°C), or acute illness at the time of enrollment.
- History of gonorrhea at any time (either self-reported or medically confirmed) or confirmed at screening by a positive nucleic acid amplification test (NAAT) result for Neisseria gonorrhoeae
- History of prior confirmed N. meningitidis infection
- Previous vaccination with Bexsero or any meningococcal serogroup B vaccine (including self-report)
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 |
|---|---|---|
| LTB-NG6LTB-NG6 administrated at 5 different doses | Biological | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 |
| Sodium Chloride 0.9%sodium chloride 0.9% used as a diluent in LTB-NG6 and as a placebo | Other | Placebo |
Primary outcome
Safety: local and systemic AEs (7-days-post)
Time frame: During 7 days following each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: - Percentage of participants reporting each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).
Safety: any events after each injection
Time frame: During 28 days following each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants reporting any adverse event (AE) following each injection * Percentage of participants reporting each severity level (Grade 1-4) of solicited local, systemic and unsolicited AEs following each injection
Safety: unsolicited AEs, SAEs, MAAEs
Time frame: Through study completion, an average of 18 months
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants with unsolicited AEs. * Percentage of participants with serious adverse events (SAEs) following each injection. * Percentage of participants with medically attended adverse events (MAAEs) following each injection.
Immunogenicity - primary IgGs GMT
Time frame: At 28 days after the second injection
To evaluate the immunogenicity of different doses of LTB-NG6 to identify the preferred dose(s). Serum IgG geometric mean titers (GMTs) against each of the N. gonorrhoeae antigens included in LTB-NG6 summarized by treatment group
3 secondary outcomes
Immunogenicity - secondary IgGs
Time frame: At baseline and 28 days after the second injection
Safety: AEs relatedness to injection, vaccine vs. placebo
Time frame: Through study completion, an average of 18 months
Safety: lab abnormalities
Time frame: At baseline and 7 days after each injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 10417159Hedges SR, Mayo MS, Mestecky J, Hook EW 3rd, Russell MW. Limited local and systemic antibody responses to Neisseria gonorrhoeae during uncomplicated genital infections. Infect Immun. 1999 Aug;67(8):3937-46. doi: 10.1128/IAI.67.8.3937-3946.1999.
- Background: PubMed 28705462Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, Black S. Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study. Lancet. 2017 Sep 30;390(10102):1603-1610. doi: 10.1016/S0140-6736(17)31449-6. Epub 2017 Jul 10.
- Background: PubMed 31681305Russell MW, Jerse AE, Gray-Owen SD. Progress Toward a Gonococcal Vaccine: The Way Forward. Front Immunol. 2019 Oct 15;10:2417. doi: 10.3389/fimmu.2019.02417. eCollection 2019.
- Background: PubMed 28686231Wi T, Lahra MM, Ndowa F, Bala M, Dillon JR, Ramon-Pardo P, Eremin SR, Bolan G, Unemo M. Antimicrobial resistance in Neisseria gonorrhoeae: Global surveillance and a call for international collaborative action. PLoS Med. 2017 Jul 7;14(7):e1002344. doi: 10.1371/journal.pmed.1002344. eCollection 2017 Jul.
- Background: PubMed 16239559Zhu W, Thomas CE, Chen CJ, Van Dam CN, Johnston RE, Davis NL, Sparling PF. Comparison of immune responses to gonococcal PorB delivered as outer membrane vesicles, recombinant protein, or Venezuelan equine encephalitis virus replicon particles. Infect Immun. 2005 Nov;73(11):7558-68. doi: 10.1128/IAI.73.11.7558-7568.2005.
- Background: PubMed 35642527Bruxvoort KJ, Lewnard JA, Chen LH, Tseng HF, Chang J, Veltman J, Marrazzo J, Qian L. Prevention of Neisseria gonorrhoeae With Meningococcal B Vaccine: A Matched Cohort Study in Southern California. Clin Infect Dis. 2023 Feb 8;76(3):e1341-e1349. doi: 10.1093/cid/ciac436.
- Background: PubMed 35427490Abara WE, Bernstein KT, Lewis FMT, Schillinger JA, Feemster K, Pathela P, Hariri S, Islam A, Eberhart M, Cheng I, Ternier A, Slutsker JS, Mbaeyi S, Madera R, Kirkcaldy RD. Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhoea: a retrospective observational study. Lancet Infect Dis. 2022 Jul;22(7):1021-1029. doi: 10.1016/S1473-3099(21)00812-4. Epub 2022 Apr 12.
- Background: PubMed 37662926Belcher T, Rollier CS, Dold C, Ross JDC, MacLennan CA. Immune responses to Neisseria gonorrhoeae and implications for vaccine development. Front Immunol. 2023 Aug 17;14:1248613. doi: 10.3389/fimmu.2023.1248613. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 LTB-NG6 and Sodium Chloride 0.9% in people with Neisseria Gonorrhea, run by LimmaTech Biologics AG 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 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steffen Haffner, Dr. (+49 731 9840 452, Steffen.Haffner@nuvisan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: local and systemic AEs (7-days-post) (time frame: During 7 days following each injection). The study lists 4 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 NCT07758972, which also lists 8 linked publications.
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 23 Sep 2026.