RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Obesity and Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

Mesa

Investigative site, Mesa, Arizona, United States, 85225

Los Angeles

Investigative site, Los Angeles, California, United States, 90057

Cooper City

Investigative site, Cooper City, Florida, United States, 33024

Hialeah

New Generation of Medical Research, Hialeah, Florida, United States, 33016

Jacksonville

Investigative Site, Jacksonville, Florida, United States, 32216

Marrero

Investigative Sites, Marrero, Louisiana, United States, 70006

Columbus

Investigative Site, Columbus, Ohio, United States, 43213

Dallas

Investigative Site, Dallas, Texas, United States, 75230

Manassas

Investigative Site, Manassas, Virginia, United States, 20110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥6.5% (48 mmol/mol) but \< 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NodThera Limited,

Study Record Dates

2026-03-31