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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
Investigative site
Mesa, Arizona, United States
Investigative site
Los Angeles, California, United States
Investigative site
Cooper City, Florida, United States
Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP
Time frame: Baseline to Week 24
Change in body weight in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
HbA1c in participants with T2DM
Time frame: Baseline to Week 24
Change in body weight in participants with obesity with and without T2DM
Time frame: Baseline to week 4, 8, 12, 16 and 20
Change in waist circumference in participants with obesity with and without T2DM
Time frame: Baseline to week 4, 8, 12, 16, 20 and 24
Change in waist/height ratio in participants with obesity with and without T2DM
Time frame: Baseline to week 4, 8, 12, 16, 20 and 24
Incidence of body weight loss ≥5% in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Incidence of body weight loss ≥10% in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Incidence of body weight loss ≥15% in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Change in metabolic biomarker in participants with and without T2DM
Time frame: Baseline to Week 24
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Investigative Site
Hialeah, Florida, United States
Investigative Site
Jacksonville, Florida, United States
Investigative Site
Miami, Florida, United States
Investigative Site
Port Orange, Florida, United States
Investigative Sites
Marrero, Louisiana, United States
Investigative Site
Columbus, Ohio, United States
Investigative Site
Dallas, Texas, United States
...and 1 more locations
Ratio change from baseline in hsCRP
Time frame: Weeks 4, 8, 12, 16, and 20
Time-averaged ratio change from baseline in hsCRP
Time frame: Between weeks 4 and 24.
Time-to- achievement of hsCRP < 2mg/L in the subset of subjects > 2mg/L at baseline
Time frame: Baseline to Week 24
Ratio change from baseline in fibrinogen
Time frame: Weeks 4, 8, 12, 16, 20 and 24.
Change in lean mass as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Change in bone mineral density as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
Incidence of adverse events in participants with obesity with and without T2DM
Time frame: Baseline to Week 28
Pharmacokinetics (PK); Area Under the Concentration vs. Time curve of NT0796 in participants with obesity with and without T2DM
Time frame: Baseline to Week 24
PK; Maximum Plasma Concentration (Cmax) of NT0796 in participants with obesity with and without T2DM
Time frame: Baseline to Week 24