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

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.

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.