Obesity and Type 2 DiabetesPhase 2RESOLVE-1NCT07055516
Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus
A Phase 2 study testing NT-0796 in people with Obesity and Type 2 Diabetes, run by Rezera (formerly NodThera Limited) at 11 sites in United States.
Trial summary
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes 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 and Type 2 Diabetes
- 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
- 176 participants
- Where
- 11 sitesUnited States
- Study dates
- 8 May 2025to 27 May 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 kilogram/square meter (kg/m2) and <40.0 kg/m2. (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.
- Group 1: Have a diagnosis of T2DM, with HbA1c < 10% (86 mmol/mol) (measured at central lab during screening) and are on stable treatment for T2DM for at least 90 days prior to screening.
- Group 2: No diagnosis or signs/symptoms of T2DM and HbA1c < 6.5% (48 mmol/mol), measured at the central lab during screening.
Who cannot join
- T1DM, or a history of ketoacidosis, or hyperosmolar state/coma requiring hospitalization at any time prior to screening.
- Have had 1 or more episode(s) of severe hypoglycemia in the 6 months prior to screening (Level 3 ADA 2025) defined as a severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycemia irrespective of glucose level, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any participant that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded.
- 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.
- Diagnosis of congestive heart failure (CHF) or clinical evidence suggesting CHF including history of orthopnea, exertional dyspnea, pedal edema, pulmonary rales, hepatosplenomegaly or cardiomegaly at the discretion of the Principal Investigator.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Investigative Site
Columbus, Ohio, 43213
Investigative site
Cooper City, Florida, 33024
Investigative Site
Dallas, Texas, 75230
Investigative Site
Hialeah, Florida, 33016
Investigative Site
Jacksonville, Florida, 32216
Investigative site
Los Angeles, California, 90057
Investigative Site
Manassas, Virginia, 20110
Investigative Sites
Marrero, Louisiana, 70006
Investigative site
Mesa, Arizona, 85225
Investigative Site
Miami, Florida, 33147
Investigative Site
Port Orange, Florida, 32127
About this study
Official title: A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes 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 randomized 1:1:1 within each strata (T2DM or non-T2DM) to either NT-0796 twice daily (BID), NT-0796 once daily (QD) or placebo (BID). Study drug will be administered orally. Following 24 weeks of active treatment, participants will enter a 4-week safety follow-up before being discharged from the study. The primary endpoint of the study will be percentage weight change from baseline, the key-secondary endpoint will be change in HbA1c from baseline in the T2DM stratum, while secondary endpoints include DEXA scans, a variety of other relevant biometric measures as well as biomarkers. Pharmacokinetic, safety and tolerability as well as suicidality will also be assessed.
- Conditions
- Obesity and Type 2 Diabetes
- Being tested
- NT-0796, Placebo
- Keywords
- NLRP3, T2DM, NT-0796, Obesity, RESOLVE-1, Rezera Inc
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
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 24 weeks, containing NT-0796 twice daily Receives: Drug: NT-0796 |
| Once daily orally administered NT-0796 capsules and placebo second daily dose | Experimental | Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 once daily, with once daily placebo Receives: Drug: NT-0796; Drug: Placebo |
| Placebo orally administered capsule | Placebo comparator | Participants will receive placebo twice daily orally for up to 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP
Measured: Baseline to Week 24
Change in body weight in participants with obesity with and without T2DM
Measured: Baseline to Week 24
Secondary outcomes (17)
HbA1c in participants with T2DM
Measured: Baseline to Week 24
Change in body weight in participants with obesity with and without T2DM
Measured: Baseline to week 4, 8, 12, 16 and 20
Change in waist circumference in participants with obesity with and without T2DM
Measured: Baseline to week 4, 8, 12, 16, 20 and 24
Change in waist/height ratio in participants with obesity with and without T2DM
Measured: Baseline to week 4, 8, 12, 16, 20 and 24
Incidence of body weight loss ≥5% in participants with obesity with and without T2DM
Measured: Baseline to Week 24
Incidence of body weight loss ≥10% in participants with obesity with and without T2DM
Measured: Baseline to Week 24
Incidence of body weight loss ≥15% in participants with obesity with and without T2DM
Measured: Baseline to Week 24
Change in metabolic biomarker in participants with and without T2DM
Measured: Baseline to Week 24
Ratio change from baseline in hsCRP
Measured: Weeks 4, 8, 12, 16, and 20
Time-averaged ratio change from baseline in hsCRP
Measured: Between weeks 4 and 24.
Time-to- achievement of hsCRP < 2mg/L in the subset of subjects > 2mg/L at baseline
Measured: Baseline to Week 24
Ratio change from baseline in fibrinogen
Measured: Weeks 4, 8, 12, 16, 20 and 24.
Change in lean mass as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM
Measured: Baseline to Week 24
Change in bone mineral density as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM
Measured: Baseline to Week 24
Incidence of adverse events in participants with obesity with and without T2DM
Measured: Baseline to Week 28
Pharmacokinetics (PK); Area Under the Concentration vs. Time curve of NT0796 in participants with obesity with and without T2DM
Measured: Baseline to Week 24
PK; Maximum Plasma Concentration (Cmax) of NT0796 in participants with obesity with and without T2DM
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 posted9 Jul 2025
- Study start8 May 2025
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Type 2 DiabetesStudies 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
- 176 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
- NCT07055516
- Sponsor's protocol ID
- NT-0796-P004
- Acronym
- RESOLVE-1
- Status last verified
- Sep 2026
- First submitted
- 30 May 2025
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07055516
- Acronym / sponsor ID
- RESOLVE-1 / NT-0796-P004
- Conditions
- Obesity and Type 2 Diabetes
- Keywords
- NLRP3, T2DM, NT-0796, Obesity, RESOLVE-1, Rezera Inc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Rezera (formerly NodThera Limited)Industry (pharma, biotech, devices)
- Study start
- 8 May 2025 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 9 Jul 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 Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes 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 randomized 1:1:1 within each strata (T2DM or non-T2DM) to either NT-0796 twice daily (BID), NT-0796 once daily (QD) or placebo (BID). Study drug will be administered orally. Following 24 weeks of active treatment, participants will enter a 4-week safety follow-up before being discharged from the study. The primary endpoint of the study will be percentage weight change from baseline, the key-secondary endpoint will be change in HbA1c from baseline in the T2DM stratum, while secondary endpoints include DEXA scans, a variety of other relevant biometric measures as well as biomarkers. Pharmacokinetic, safety and tolerability as well as suicidality will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Twice daily orally administered NT-0796 capsule | Experimental | Drug: NT-0796Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 twice daily |
| Once daily orally administered NT-0796 capsules and placebo second daily dose | Experimental | Drug: NT-0796, Drug: PlaceboParticipants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 once daily, with once daily placebo |
| Placebo orally administered capsule | Placebo comparator | Drug: PlaceboParticipants will receive placebo twice daily orally for up to 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 kilogram/square meter (kg/m2) and <40.0 kg/m2. (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.
- Group 1: Have a diagnosis of T2DM, with HbA1c < 10% (86 mmol/mol) (measured at central lab during screening) and are on stable treatment for T2DM for at least 90 days prior to screening.
- Group 2: No diagnosis or signs/symptoms of T2DM and HbA1c < 6.5% (48 mmol/mol), measured at the central lab during screening.
Key exclusion criteria (5 listed)
- T1DM, or a history of ketoacidosis, or hyperosmolar state/coma requiring hospitalization at any time prior to screening.
- Have had 1 or more episode(s) of severe hypoglycemia in the 6 months prior to screening (Level 3 ADA 2025) defined as a severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycemia irrespective of glucose level, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any participant that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded.
- 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.
- Diagnosis of congestive heart failure (CHF) or clinical evidence suggesting CHF including history of orthopnea, exertional dyspnea, pedal edema, pulmonary rales, hepatosplenomegaly or cardiomegaly at the discretion of the Principal Investigator.
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 | Once daily orally administered NT-0796 capsules and placebo second daily dose, Twice daily orally administered NT-0796 capsule |
| PlaceboOrally administered capsules | Drug | Once daily orally administered NT-0796 capsules and placebo second daily dose, Placebo orally administered capsule |
Primary outcome
Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP
Time frame: Baseline to Week 24
Change in body weight in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
17 secondary outcomes
HbA1c in participants with T2DM
Time frame: Baseline to Week 24
Change in body weight in participants with obesity with and without T2DM
Time frame: Baseline to week 4, 8, 12, 16 and 20
Change in waist circumference in participants with obesity with and without T2DM
Time frame: Baseline to week 4, 8, 12, 16, 20 and 24
Change in waist/height ratio in participants with obesity with and without T2DM
Time frame: Baseline to week 4, 8, 12, 16, 20 and 24
Incidence of body weight loss ≥5% in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Incidence of body weight loss ≥10% in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Incidence of body weight loss ≥15% in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Change in metabolic biomarker in participants with and without T2DM
Time frame: Baseline to Week 24
Ratio change from baseline in hsCRP
Time frame: Weeks 4, 8, 12, 16, and 20
Time-averaged ratio change from baseline in hsCRP
Time frame: Between weeks 4 and 24.
Time-to- achievement of hsCRP < 2mg/L in the subset of subjects > 2mg/L at baseline
Time frame: Baseline to Week 24
Ratio change from baseline in fibrinogen
Time frame: Weeks 4, 8, 12, 16, 20 and 24.
Change in lean mass as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Change in bone mineral density as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Incidence of adverse events in participants with obesity with and without T2DM
Time frame: Baseline to Week 28
Pharmacokinetics (PK); Area Under the Concentration vs. Time curve of NT0796 in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
PK; Maximum Plasma Concentration (Cmax) of NT0796 in participants with obesity with and without T2DM
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 15 Sep 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.
11 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 and Type 2 Diabetes, run by Rezera (formerly NodThera Limited) at 11 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 5 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 15 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 11 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?
Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP (time frame: Baseline to Week 24). 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?
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 15 Sep 2026.