Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 D… (NCT07055516) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus
United States176 participantsStarted 2025-05-08
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
Exclusion Criteria:
* 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 …
What they're measuring
1
Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP
Timeframe: Baseline to Week 24
2
Change in body weight in participants with obesity with and without T2DM