ObesityPhase 2RESOLVE-2NCT07220629
Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)
A Phase 2 study testing NT-0796 in people with Obesity, run by Rezera (formerly NodThera Limited) at 9 sites in United States.
Trial summary
A Phase 2a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to explore the safety and efficacy of NT-0796 as an adjunct to semaglutide in participants with obesity over a 6 months treatment period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- 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
- 82 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Oct 2025to 21 Aug 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 years (inclusive) at Screening who have signed informed consent and are willing and able to comply with the study protocol.
- Have a BMI of ≥30.0 kg/m2 and <45.0 kg/m2 at Screening. (BMI values should be calculated to one decimal point precision and then assessed in terms of the required range).
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI.
Who cannot join
- Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening.
- Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide.
- Type 1 or Type 2 Diabetes Mellitus (T1DM or T2DM), and/or HbA1c ≥6.5% (48 mmol/mol) at Screening and/or use of any anti-diabetic medications.
- History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1.
- History of acute coronary syndrome (ACS) including unstable angina, acute myocardial infarction (both ST segment elevation and non-ST segment elevation) within 6 months prior to Day 1.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Investigative Site
Columbus, Ohio, 43213
Investigative Site
Hialeah, Florida, 33016
Investigative Site
Jacksonville, Florida, 32216
Investigative Site
Manassas, Virginia, 20110
Investigative Site
Marrero, Louisiana, 70006
Investigative Site
Mesa, Arizona, 85225
Investigative Site
Miami, Florida, 33147
Investigative Site
Salt Lake City, Utah, 84124
Investigative Site
Seabrook, Texas, 77586
About this study
Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide Plus a Reduced Calorie Diet and Increased Physical Activity in Participants With Obesity
A Phase 2a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to explore the safety and efficacy of NT-0796 as an adjunct to semaglutide in participants with obesity over a 6 months treatment period.
Read the detailed description
Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomly assigned to receive the Investigational Medicinal Product (IMP, either NT-0796 or placebo) twice daily (BID). All participants will receive sc semaglutide. The IMP will be administered orally. Semaglutide will be initiated and titrated using a fixed, 4-weekly dose escalation scheme, as per the approved USPI.
Following 32 weeks of active treatment, participants will enter a 4-week safety follow-up period before being discharged from the study. Semaglutide will be provided for the period from baseline (Day 1) up until completion of the 4-week safety follow-up.
The Primary Endpoint of the study will be the safety and tolerability of NT-0796 as an adjunct to semaglutide, the key secondary endpoint will be the effect of NT-0796 as an adjunct to semaglutide on weight loss while secondary endpoints include percentage weight change from baseline.
- Conditions
- Obesity
- Being tested
- NT-0796, Placebo
- Keywords
- RESOLVE -2, Obesity, NLRP3, NT-0796, Rezera Inc.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-0796Drug
Orally administered capsules
PlaceboDrug
Orally administered capsules
| Study group | Role | What they receive |
|---|---|---|
| Twice daily orally administered NT-0796 capsule | Experimental | Participants will receive study medication twice daily orally for up to 32 weeks, containing NT-0796 twice daily Receives: Drug: NT-0796 |
| Placebo orally administered capsule | Placebo comparator | Participants will receive placebo twice daily orally for up to 32 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide in participants with obesity by assessing AEs and SAEs, symptoms of nausea and vomiting, clinical laboratory parameters, vital signs and ECGs.
Measured: Baseline to Week 24
Secondary outcomes (11)
Ratio change from baseline to Week 20 in hsCRP
Measured: Baseline to Week 20
Ratio change from baseline to Week 20 in Fibrinogen
Measured: Baseline to Week 20
Percent change in body weight in participants with obesity
Measured: Baseline to Week 20
Ratio change from baseline in hsCRP (mg/L)
Measured: Weeks 4, 8, 12, 16, 24, 28, 32 and 36
Time-averaged ratio change from baseline in hsCRP (mg/L)
Measured: Between weeks 4 and 32.
Time-to- achievement of hsCRP (mg/L) < 2, in the subset of subjects > 2 at baseline
Measured: Baseline to Week 32
Ratio change from baseline in fibrinogen (mg/dL)
Measured: Weeks 4, 8, 12, 16, 24, 28, 32 and 36
Percent change in body weight in participants with obesity
Measured: Baseline to Weeks 4, 8, 12, 16, 24, 28, 32, 36
Change in waist circumference and waist/height ratio
Measured: Baseline to Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36
Proportion of participants that achieve a body weight reduction of ≥5%, ≥10% or ≥15%
Measured: Baseline to Week 4, 8, 12, 16, 20, 24, 28, 32, 36
NT-0796/NDT-19795 concentrations in plasma
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start2 Oct 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 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
- NCT07220629
- Sponsor's protocol ID
- NT-0796-P006
- Acronym
- RESOLVE-2
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide Plus a Reduced Calorie Diet and Increased Physical Activity in Participants With Obesity
- ClinicalTrials.gov ID
- NCT07220629
- Acronym / sponsor ID
- RESOLVE-2 / NT-0796-P006
- Conditions
- Obesity
- Keywords
- RESOLVE -2, Obesity, NLRP3, NT-0796, Rezera Inc.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Rezera (formerly NodThera Limited)Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 24 Oct 2025 (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.
A Phase 2a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to explore the safety and efficacy of NT-0796 as an adjunct to semaglutide in participants with obesity over a 6 months treatment period.
Detailed description
Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomly assigned to receive the Investigational Medicinal Product (IMP, either NT-0796 or placebo) twice daily (BID). All participants will receive sc semaglutide. The IMP will be administered orally. Semaglutide will be initiated and titrated using a fixed, 4-weekly dose escalation scheme, as per the approved USPI.
Following 32 weeks of active treatment, participants will enter a 4-week safety follow-up period before being discharged from the study. Semaglutide will be provided for the period from baseline (Day 1) up until completion of the 4-week safety follow-up.
The Primary Endpoint of the study will be the safety and tolerability of NT-0796 as an adjunct to semaglutide, the key secondary endpoint will be the effect of NT-0796 as an adjunct to semaglutide on weight loss while secondary endpoints include percentage weight change from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twice daily orally administered NT-0796 capsule | Experimental | Drug: NT-0796Participants will receive study medication twice daily orally for up to 32 weeks, containing NT-0796 twice daily |
| Placebo orally administered capsule | Placebo comparator | Drug: PlaceboParticipants will receive placebo twice daily orally for up to 32 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 to 75 years (inclusive) at Screening who have signed informed consent and are willing and able to comply with the study protocol.
- Have a BMI of ≥30.0 kg/m2 and <45.0 kg/m2 at Screening. (BMI values should be calculated to one decimal point precision and then assessed in terms of the required range).
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI.
Key exclusion criteria (5 listed)
- Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening.
- Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide.
- Type 1 or Type 2 Diabetes Mellitus (T1DM or T2DM), and/or HbA1c ≥6.5% (48 mmol/mol) at Screening and/or use of any anti-diabetic medications.
- History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1.
- History of acute coronary syndrome (ACS) including unstable angina, acute myocardial infarction (both ST segment elevation and non-ST segment elevation) within 6 months prior to Day 1.
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 | Twice daily orally administered NT-0796 capsule |
| PlaceboOrally administered capsules | Drug | Placebo orally administered capsule |
Primary outcome
Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide in participants with obesity by assessing AEs and SAEs, symptoms of nausea and vomiting, clinical laboratory parameters, vital signs and ECGs.
Time frame: Baseline to Week 24
11 secondary outcomes
Ratio change from baseline to Week 20 in hsCRP
Time frame: Baseline to Week 20
Ratio change from baseline to Week 20 in Fibrinogen
Time frame: Baseline to Week 20
Percent change in body weight in participants with obesity
Time frame: Baseline to Week 20
Ratio change from baseline in hsCRP (mg/L)
Time frame: Weeks 4, 8, 12, 16, 24, 28, 32 and 36
Time-averaged ratio change from baseline in hsCRP (mg/L)
Time frame: Between weeks 4 and 32.
Time-to- achievement of hsCRP (mg/L) < 2, in the subset of subjects > 2 at baseline
Time frame: Baseline to Week 32
Ratio change from baseline in fibrinogen (mg/dL)
Time frame: Weeks 4, 8, 12, 16, 24, 28, 32 and 36
Percent change in body weight in participants with obesity
Time frame: Baseline to Weeks 4, 8, 12, 16, 24, 28, 32, 36
Change in waist circumference and waist/height ratio
Time frame: Baseline to Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36
Proportion of participants that achieve a body weight reduction of ≥5%, ≥10% or ≥15%
Time frame: Baseline to Week 4, 8, 12, 16, 20, 24, 28, 32, 36
NT-0796/NDT-19795 concentrations in plasma
Time frame: Baseline to Week 24
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.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT-0796 in people with Obesity, run by Rezera (formerly NodThera Limited) at 9 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 4 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 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide in participants with obesity by assessing AEs and SAEs, symptoms of nausea and vomiting, clinical laboratory parameters, vital signs and ECGs. (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.