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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 14
- 主要终点
- Change in body weight in participants with obesity with and without T2DM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •(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.
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
Once daily orally administered NT-0796 capsules and placebo second daily dose
Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 once daily, with once daily placebo
干预措施: NT-0796 (Drug)
Once daily orally administered NT-0796 capsules and placebo second daily dose
Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 once daily, with once daily placebo
干预措施: Placebo (Drug)
Placebo orally administered capsule
Participants will receive placebo twice daily orally for up to 24 weeks
干预措施: Placebo (Drug)
Twice daily orally administered NT-0796 capsule
Participants will receive study medication twice daily orally for up to 24 weeks, containing NT-0796 twice daily
干预措施: NT-0796 (Drug)
结局指标
主要结局
Change in body weight in participants with obesity with and without T2DM
时间窗: Baseline to Week 24
Ratio Change in hsCRP in participants with obesity and without T2DM hsCRP
时间窗: Baseline to Week 24
次要结局
- 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)
- Incidence of body weight loss ≥10% in participants with obesity with and without T2DM(Baseline to Week 24)
- Incidence of body weight loss ≥15% in participants with obesity with and without T2DM(Baseline to Week 24)
- Change in metabolic biomarker in participants with and without T2DM(Baseline to Week 24)
- Change in lean mass as measured by Dual-energy Xray absorptiometry (DEXA) in participants with obesity with and without T2DM(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(Baseline to Week 24)
- Incidence of adverse events in participants with obesity with and without T2DM(Baseline to Week 28)
- Pharmacokinetics (PK); Area Under the Concentration vs. Time curve of NT0796 in participants with obesity with and without T2DM(Baseline to Week 24)
- PK; Maximum Plasma Concentration (Cmax) of NT0796 in participants with obesity with and without T2DM(Baseline to Week 24)
- Ratio change from baseline in hsCRP(Weeks 4, 8, 12, 16, and 20)
- Time-averaged ratio change from baseline in hsCRP(Between weeks 4 and 24.)
- Time-to- achievement of hsCRP < 2mg/L in the subset of subjects > 2mg/L at baseline(Baseline to Week 24)
- Ratio change from baseline in fibrinogen(Weeks 4, 8, 12, 16, 20 and 24.)