Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)
- Registration Number
- NCT07220629
- Lead Sponsor
- NodThera Limited
- Brief 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.
- Detailed Description
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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Twice daily orally administered NT-0796 capsule NT-0796 Participants will receive study medication twice daily orally for up to 20 weeks, containing NT-0796 twice daily Placebo orally administered capsule Placebo Participants will receive placebo twice daily orally for up to 20 weeks
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Proportion of participants that achieve a body weight reduction of ≥5%, ≥10% or ≥15% Baseline to Week 20 NT-0796/NDT-19795 concentrations in plasma Baseline to Week 24 Percent change in body weight in participants with obesity Baseline to Weeks 4, 8, 12, 16, and 24 Change in waist circumference and waist/height ratio Baseline to Weeks 4, 8, 12, 16, 20, and 24
Trial Locations
- Locations (1)
Investigative Site
🇺🇸Manassas, Virginia, United States
Investigative Site🇺🇸Manassas, Virginia, United States