NCT07055516CompletedPhase 2
Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NT-0796 as an Adjunct to a Reduced Calorie Diet and Increased Physical Activity in Obese Participants With/Without Type 2 Diabetes over a 6 months treatment period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 176 (actual)
- First submitted
- 30 May 2025
- Start date
- 8 May 2025
- Primary completion date
- 27 May 2026
- Lead sponsor
- Rezera (formerly NodThera Limited)
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07055516
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 176
- From 8 May 2025 to the primary completion date, 27 May 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- T1DM, or a history of ketoacidosis, or hyperosmolar state/coma requiring hospitalization at any time prior to screening.
- 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.
Other illness
- Diagnosis of congestive heart failure (CHF) or clinical evidence suggesting CHF including history of orthopnea, exertional dyspnea, pedal edema, pulmonary rales, hepatosplenomegaly or cardiomegaly at the discretion of the Principal Investigator.
Lab values
- Have had 1 or more episode(s) of severe hypoglycemia in the 6 months prior to screening (Level 3 ADA 2025) defined as a severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycemia irrespective of glucose level, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any participant that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded.
Who the study is looking for
- 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 kilogram/square meter (kg/m2) and \<40.0 kg/m2. (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.
- Group 1: Have a diagnosis of T2DM, with HbA1c \< 10% (86 mmol/mol) (measured at central lab during screening) and are on stable treatment for T2DM for at least 90 days prior to screening.
- Group 2: No diagnosis or signs/symptoms of T2DM and HbA1c \< 6.5% (48 mmol/mol), measured at the central lab during screening.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cooper City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.