Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT07220629
- Run by
- NodThera Limited
- People needed
- 82
- Starts
- 2025-10-02
- Expected to finish
- 2026-08-21
- Last updated by the study team
- 2026-04-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Investigative Site — Mesa, Arizona, 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
Full record on ClinicalTrials.gov
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