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)

United States82 participantsStarted 2025-10-02

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

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.

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT07220629

SponsorNodThera Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-21

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