Cardiovascular DiseasesPhase 1NCT06129409
Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease
A Phase 1 study testing NT-0796 in people with Cardiovascular Diseases, run by Rezera (formerly NodThera Limited) at 2 sites in United States.
Trial summary
This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease. Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- NT-0796
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2023to 15 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older.
- Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening.
- Presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease:
- History of controlled hypertension
- History of hypercholesterolemia
- History of high-density lipoprotein levels
- Controlled Type 1 or Type 2 Diabetes mellitus
Who cannot join
- History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months
- History of acute coronary syndrome (ACS)
- Stable angina.
- Diagnosis of congestive heart failure
- Evidence of past or current infection with Hepatitis B or Hepatitis C
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Investigative Site
Austin, Texas, 78744
Investigative Site
Miami, Florida, 33147
About this study
Official title: A Randomized, Double -Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease
This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease.
Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment.
For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.
Read the detailed description
The goal of this clinical trial is to evaluate the effects of NT-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of NT-0796 on body weight and composition, to see how safe NT-0796 is, and how well it is tolerated and to measure the blood levels of NT-0796, with and without food.
- Conditions
- Cardiovascular Diseases
- Being tested
- NT-0796
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-0796Drug
Orally administered capsules
| Study group | Role | What they receive |
|---|---|---|
| NT-0796 | Experimental | BID Receives: Drug: NT-0796 |
| Placebo | Placebo comparator | BID Receives: Drug: NT-0796 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP levels
Evaluate the effects of NT-0796 on inflammation.
Measured: Baseline to Day 28
Secondary outcomes (2)
Change in Body weight (kg)
Measured: Change from baseline to Day 28
Body composition
Absolute Fat mass, % Body Fat and Visceral Fat (L)
Measured: Change from baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start10 Oct 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
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 Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug vs Placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rezera (formerly NodThera Limited)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129409
- Sponsor's protocol ID
- NT-0796-P003
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ray KK, Clarke N, Thornton P, Miles AE, Digby Z, Davies MJ, Gorman M, Mullen B, Reader V, Magill M, Johnstone H, Ariti C, Sattar N, Marx N, Navar AM, Hernandez AF, George JT, Watt AP, Butler J, Ridker PM. Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk. J Am Coll Cardiol. 2026 May 26:S0735-1097(26)06570-8. doi: 10.1016/j.jacc.2026.05.014. Online ahead of print.
PubMed 42187339
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double -Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06129409
- Acronym / sponsor ID
- NT-0796-P003
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Rezera (formerly NodThera Limited)Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 13 Nov 2023 (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.
This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease.
Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment.
For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.
Detailed description
The goal of this clinical trial is to evaluate the effects of NT-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of NT-0796 on body weight and composition, to see how safe NT-0796 is, and how well it is tolerated and to measure the blood levels of NT-0796, with and without food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Drug vs Placebo
| Arm | Type | Receives |
|---|---|---|
| NT-0796 | Experimental | Drug: NT-0796BID |
| Placebo | Placebo comparator | Drug: NT-0796BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18 years or older.
- Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening.
- Presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease:
Key exclusion criteria (5 listed)
- History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months
- History of acute coronary syndrome (ACS)
- Stable angina.
- Diagnosis of congestive heart failure
- Evidence of past or current infection with Hepatitis B or Hepatitis C
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 |
|---|---|---|
| NT-0796Orally administered capsules | Drug | NT-0796, Placebo |
Primary outcome
Change in hsCRP levels
Time frame: Baseline to Day 28
Evaluate the effects of NT-0796 on inflammation.
2 secondary outcomes
Change in Body weight (kg)
Time frame: Change from baseline to Day 28
Body composition
Time frame: Change from baseline to Day 28
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 27 Oct 2026.
- Derived from this study: PubMed 42187339Ray KK, Clarke N, Thornton P, Miles AE, Digby Z, Davies MJ, Gorman M, Mullen B, Reader V, Magill M, Johnstone H, Ariti C, Sattar N, Marx N, Navar AM, Hernandez AF, George JT, Watt AP, Butler J, Ridker PM. Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk. J Am Coll Cardiol. 2026 May 26:S0735-1097(26)06570-8. doi: 10.1016/j.jacc.2026.05.014. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NT-0796 in people with Cardiovascular Diseases, run by Rezera (formerly NodThera Limited) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Change in hsCRP levels (time frame: Baseline to Day 28). 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 NCT06129409, 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 27 Oct 2026.