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RESOLVE-2

Active not recruitingPhase 2

Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)

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

Lead sponsor

NodThera Limited

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-45

Primary endpoint

•Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07220629

Org study IDNT-0796-P006

Timeline

Milestones

Study start2025-10-02actual

Study first posted2025-10-24actual

Last update posted2026-04-08actual

Primary completion2026-08-21estimated

Study completion2026-08-21estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. 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.

2. 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).

3. History of at least one self-reported unsuccessful dietary effort to lose body weight.

4. Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI.

Exclusion criteria

1. Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening.

2. Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide.

3. 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.

4. History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1.

5. 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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Percent change in body weight in participants with obesity

Time frame:Baseline to Week 20

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight in participants with obesity

Time frame:Baseline to Weeks 4, 8, 12, 16, 24, 28, 32, 36

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference and waist/height ratio

Time frame:Baseline to Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

≥5% weight-loss responders

threshold achievement, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Ratio change from baseline to Week 20 in hsCRP

Time frame:Baseline to Week 20

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ratio change from baseline to Week 20 in Fibrinogen

Time frame:Baseline to Week 20

Fibrinogen, change

change from baseline, improvement

Secondary/protocol endpoint

Ratio change from baseline in hsCRP (mg/L)

Time frame:Weeks 4, 8, 12, 16, 24, 28, 32 and 36

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Time-averaged ratio change from baseline in hsCRP (mg/L)

Time frame:Between weeks 4 and 32.

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Time-to- achievement of hsCRP (mg/L) < 2, in the subset of subjects > 2 at baseline

Time frame:Baseline to Week 32

hs-CRP, change

time to event, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ratio change from baseline in fibrinogen (mg/dL)

Time frame:Weeks 4, 8, 12, 16, 24, 28, 32 and 36

Fibrinogen, change

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

NT-0796/NDT-19795 concentrations in plasma

Time frame:Baseline to Week 24

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.