Status:
ACTIVE_NOT_RECRUITING
Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)
Lead Sponsor:
NodThera Limited
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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-0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07220629
Start Date
October 2 2025
End Date
June 1 2026
Last Update
December 23 2025
Active Locations (10)
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1
Investigative Site
Mesa, Arizona, United States, 85225
2
Investigative Site
Cooper City, Florida, United States, 33024
3
Investigative Site
Hialeah, Florida, United States, 33016
4
Investigative Site
Jacksonville, Florida, United States, 32216