{ "data": { "asOf": "2026-10-30T22:25:43.897Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07220629", "title": "Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)", "scientificTitle": "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", "status": "completed", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Obesity" ], "interventions": [ { "name": "NT-0796", "type": "DRUG", "description": "Orally administered capsules" }, { "name": "Placebo", "type": "DRUG", "description": "Orally administered capsules" } ], "sponsor": { "name": "Rezera (formerly NodThera Limited)", "type": "INDUSTRY" }, "locations": [ { "city": "Mesa", "country": "United States", "facility": "Investigative Site" }, { "city": "Hialeah", "country": "United States", "facility": "Investigative Site" }, { "city": "Jacksonville", "country": "United States", "facility": "Investigative Site" }, { "city": "Miami", "country": "United States", "facility": "Investigative Site" }, { "city": "Marrero", "country": "United States", "facility": "Investigative Site" }, { "city": "Columbus", "country": "United States", "facility": "Investigative Site" }, { "city": "Seabrook", "country": "United States", "facility": "Investigative Site" }, { "city": "Salt Lake City", "country": "United States", "facility": "Investigative Site" }, { "city": "Manassas", "country": "United States", "facility": "Investigative Site" } ], "outcomes": { "other": [], "primary": [ "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." ], "secondary": [ "Ratio change from baseline to Week 20 in hsCRP", "Ratio change from baseline to Week 20 in Fibrinogen", "Percent change in body weight in participants with obesity", "Ratio change from baseline in hsCRP (mg/L)", "Time-averaged ratio change from baseline in hsCRP (mg/L)", "Time-to- achievement of hsCRP (mg/L) < 2, in the subset of subjects > 2 at baseline", "Ratio change from baseline in fibrinogen (mg/dL)", "Percent change in body weight in participants with obesity", "Change in waist circumference and waist/height ratio", "Proportion of participants that achieve a body weight reduction of ≥5%, ≥10% or ≥15%", "NT-0796/NDT-19795 concentrations in plasma" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. 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.\n2. 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).\n3. History of at least one self-reported unsuccessful dietary effort to lose body weight.\n4. Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI.\n\nExclusion Criteria:\n\n1. Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening.\n2. Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide.\n3. 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.\n4. History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day 1.\n5. 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