Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity and Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT07055516

Run by

NodThera Limited

People needed

176

Starts

2025-05-08

Expected to finish

2026-05-27

Last updated by the study team

2026-06-30

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 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.

You may not qualify if…

• T1DM, or a history of ketoacidosis, or hyperosmolar state/coma requiring hospitalization at any time prior to screening.
• 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.
• 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.
• 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.

Where it is running

• Investigative site — Mesa, Arizona, United States
• Investigative site — Los Angeles, California, United States
• Investigative site — Cooper City, Florida, United States
• Investigative Site — Hialeah, Florida, United States
• Investigative Site — Jacksonville, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Port Orange, Florida, United States
• Investigative Sites — Marrero, Louisiana, United States
• Investigative Site — Columbus, Ohio, United States
• Investigative Site — Dallas, Texas, United States
• Investigative Site — Manassas, Virginia, United States

Full record on ClinicalTrials.gov

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