Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)
NCT ID: NCT07220629
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-10-02
2026-06-01
Brief Summary
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Detailed Description
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Following 20 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Twice daily orally administered NT-0796 capsule
Participants will receive study medication twice daily orally for up to 20 weeks, containing NT-0796 twice daily
NT-0796
Orally administered capsules
Placebo orally administered capsule
Participants will receive placebo twice daily orally for up to 20 weeks
Placebo
Orally administered capsules
Interventions
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NT-0796
Orally administered capsules
Placebo
Orally administered capsules
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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NodThera Limited
INDUSTRY
Responsible Party
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Locations
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Investigative Site
Mesa, Arizona, United States
Investigative Site
Cooper City, Florida, United States
Investigative Site
Hialeah, Florida, United States
Investigative Site
Jacksonville, Florida, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Marrero, Louisiana, United States
Investigative Site
Columbus, Ohio, United States
Investigative Site
Seabrook, Texas, United States
Investigative Site
Salt Lake City, Utah, United States
Investigative Site
Manassas, Virginia, United States
Countries
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Other Identifiers
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NT-0796-P006
Identifier Type: -
Identifier Source: org_study_id