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

NodThera Limited

Status and phase: Enrolling; Phase 2

Conditions: Obesity and Type 2 Diabetes

Treatments: Drug: NT-0796; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07055516

NT-0796-P004

Details and patient eligibility

About

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.

Full description

Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomized 1:1:1 within each strata (T2DM or non-T2DM) to either NT-0796 twice daily (BID), NT-0796 once daily (QD) or placebo (BID). Study drug will be administered orally. Following 24 weeks of active treatment, participants will enter a 4-week safety follow-up before being discharged from the study. The primary endpoint of the study will be percentage weight change from baseline, the key-secondary endpoint will be change in HbA1c from baseline in the T2DM stratum, while secondary endpoints include DEXA scans, a variety of other relevant biometric measures as well as biomarkers. Pharmacokinetic, safety and tolerability as well as suicidality will also be assessed.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 ≥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.

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 3 patient groups, including a placebo group

Twice daily orally administered NT-0796 capsule

Experimental group

Description:

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

Treatment:

Drug: NT-0796

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NT-0796

Placebo orally administered capsule

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo