ACTIVE_NOT_RECRUITING

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

Conditions

Obesity and Type 2 Diabetes NLRP3 T2DM NT-0796 Obesity RESOLVE-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Quick Facts

Study Start:2025-05-08

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07055516

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

Investigative site

Mesa, Arizona, 85225

United States

Investigative site

Los Angeles, California, 90057

United States

Investigative site

Cooper City, Florida, 33024

United States

Investigative Site

Hialeah, Florida, 33016

United States

Investigative Site

Jacksonville, Florida, 32216

United States

Investigative Site

Miami, Florida, 33147

United States

Investigative Site

Port Orange, Florida, 32127

United States

Investigative Sites

Marrero, Louisiana, 70006

United States

Investigative Site

Columbus, Ohio, 43213

United States

Investigative Site

Dallas, Texas, 75230

United States

Investigative Site

Manassas, Virginia, 20110

United States

Collaborators and Investigators

Sponsor: NodThera Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-08

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-05-08

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

NLRP3
T2DM
NT-0796
Obesity
RESOLVE-1

Additional Relevant MeSH Terms

Obesity and Type 2 Diabetes