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

NCT07055516 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NT-0796-P004
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Obesity and Type 2 Diabetes

Keywords

NLRP3; T2DM; NT-0796; Obesity; RESOLVE-1

Outcome Measures

Primary Outcomes (2)

• Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP

  Baseline to Week 24

• Change in body weight in participants with obesity with and without T2DM

  Baseline to Week 24

Secondary Outcomes (17)

• HbA1c in participants with T2DM

  Baseline to Week 24

• Change in body weight in participants with obesity with and without T2DM

  Baseline to week 4, 8, 12, 16 and 20

• Change in waist circumference in participants with obesity with and without T2DM

  Baseline to week 4, 8, 12, 16, 20 and 24

• Change in waist/height ratio in participants with obesity with and without T2DM

  Baseline to week 4, 8, 12, 16, 20 and 24

• Incidence of body weight loss ≥5% in participants with obesity with and without T2DM

  Baseline to Week 24

Study Arms (3)

Twice daily orally administered NT-0796 capsule

EXPERIMENTAL

Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 twice daily

Drug: NT-0796

Once daily orally administered NT-0796 capsules and placebo second daily dose

EXPERIMENTAL

Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 once daily, with once daily placebo

Drug: NT-0796; Drug: Placebo

Placebo orally administered capsule

PLACEBO COMPARATOR

Participants will receive placebo twice daily orally for up to 24 weeks

Drug: Placebo

Interventions

NT-0796 DRUG

Orally administered capsules

Once daily orally administered NT-0796 capsules and placebo second daily dose; Twice daily orally administered NT-0796 capsule

Placebo DRUG

Orally administered capsules

Once daily orally administered NT-0796 capsules and placebo second daily dose; Placebo orally administered capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NodThera Limited: lead

Study Sites (11)

Investigative site

Mesa, Arizona, 85225, United States

Location

Investigative site

Los Angeles, California, 90057, United States

Location

Investigative site

Cooper City, Florida, 33024, United States

Location

Investigative Site

Hialeah, Florida, 33016, United States

Location

Investigative Site

Jacksonville, Florida, 32216, United States

Location

Investigative Site

Miami, Florida, 33147, United States

Location

Investigative Site

Port Orange, Florida, 32127, United States

Location

Investigative Sites

Marrero, Louisiana, 70006, United States

Location

Investigative Site

Columbus, Ohio, 43213, United States

Location

Investigative Site

Dallas, Texas, 75230, United States

Location

Investigative Site

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 9, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (11)