Clinical trial

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

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07220629

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

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.

Treatments and study arms

NT-0796

Drug

Orally administered capsules

Placebo

Drug

Orally administered capsules

Primary outcomes

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.Baseline to Week 24

Study locations

9 locations were listed when this page was built. The first 40 are shown.

Investigative Site🇺🇸 Columbus, Ohio, United States
Investigative Site🇺🇸 Hialeah, Florida, United States
Investigative Site🇺🇸 Jacksonville, Florida, United States
Investigative Site🇺🇸 Manassas, Virginia, United States
Investigative Site🇺🇸 Marrero, Louisiana, United States
Investigative Site🇺🇸 Mesa, Arizona, United States
Investigative Site🇺🇸 Miami, Florida, United States
Investigative Site🇺🇸 Salt Lake City, Utah, United States
Investigative Site🇺🇸 Seabrook, Texas, United States