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NCT Number: NCT07220629

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 in participants with obesity over a 6 months treatment period.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Mesa, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NT-0796

Drug

Orally administered capsules

Placebo

Drug

Orally administered capsules

Primary outcomes

  1. 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

Secondary outcomes

  1. Ratio change from baseline to Week 20 in hsCRP

    Time frame: Baseline to Week 20

  2. Ratio change from baseline to Week 20 in Fibrinogen

    Time frame: Baseline to Week 20

  3. Percent change in body weight in participants with obesity

    Time frame: Baseline to Week 20

  4. Ratio change from baseline in hsCRP (mg/L)

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

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

    Time frame: Between weeks 4 and 32.

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

    Time frame: Baseline to Week 32

  7. Ratio change from baseline in fibrinogen (mg/dL)

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

  8. Percent change in body weight in participants with obesity

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

  9. Change in waist circumference and waist/height ratio

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

  10. 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

  11. NT-0796/NDT-19795 concentrations in plasma

    Time frame: Baseline to Week 24

Sponsors and collaborators

Lead sponsor

Rezera (formerly NodThera Limited)

Industry

Registry information

Official study 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

Acronym: RESOLVE-2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2025
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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