NCT05925114已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Assess the Safety and Efficacy of S-309309 in Obese Adults
Shionogi48 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2023年6月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 48
- 主要终点
- Percent Change From Baseline in Body Weight
研究概览
简要总结
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of ≥ 30 kg/m^2 (obese) with or without comorbidities. An online BMI calculator is available at Calculate Your BMI - Standard BMI Calculator (nih.gov)
- •Stable body weight (defined as ≤ 5 kg of self-reported change) within 90 days prior to study start
- •Lifetime history of at least 1 unsuccessful dietary effort to lose body weight
- •Is a participant of non-childbearing potential (PONCBP) OR Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective as specified in the protocol. A POCBP must have a negative highly sensitive pregnancy test (urine or serum) before a first dose of study intervention as per protocol.
排除标准
- •Obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome)
- •Medical history or characteristics suggestive of genetic obesity
- •Any lifetime history of a suicide attempt or history of any suicidal ideation within the past year before entry into the study
- •History of documented human immunodeficiency virus (HIV) infection
- •History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
- •History of inflammatory conditions and autoimmune diseases
- •Males: a QT interval corrected using Fridericia's formula (QTcF) interval of > 450 msec at the Screening Visit; females: a QTcF interval > 470 msec at the Screening Visit
- •Active malignancy or history of malignancy (other than nonmelanoma skin cancer or any grade intraepithelial cervical neoplasia that has been surgically treated) within 5 years of enrollment in this study
- •A severe psychiatric condition, such as schizophrenia, bipolar disorder, or major depression in the previous 2 years before the Screening Visit, or history of treatment with antipsychotics, antidepressants, or mood stabilizers in the previous 2 years before the Screening Visit.
- •Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days prior to the Screening Visit
- •A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at the Screening Visit
- •History of an eating disorder (eg, bulimia or anorexia nervosa)
- •History of drug or alcohol abuse within 5 years of the Screening Visit
- •A self-reported change in body weight > 5 kg (11 pounds [lbs]) within 90 days prior to the Screening Visit
- •Known history of treated or untreated diabetes
- •Baseline hemoglobin A1c (HbA1c) ≥ 6.5% at the Screening Visit
- •Alanine aminotransaminase (ALT) > 3 × upper limit of normal (ULN) at the Screening Visit
- •Aspartate aminotransaminase (AST) > 3 × ULN at the Screening Visit
- •Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at the Screening Visit
- •Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, Gilbert's syndrome or gallstones)
- •Any underlying lens opacity that affects the BCVA, or any posterior subcapsular opacity ≥ P1 based on the LOCS III, even if not impacting the BCVA
- •Marijuana use within 90 days prior to the Screening Visit
- •Use of medications that the investigator considers to be associated with weight changes within 90 days prior to the Screening Visit
- •Concomitant or previous steroid treatments (including eye-drops, inhalers, and nebulizers) for a total of ≥ 15 days during the 24 weeks prior to the Screening Visit; dermatological preparations of steroids will be allowed
- •History of or planned bariatric surgery or intra-abdominal balloon during study participation
- •Concomitant use of any dietary or herbal supplement that is indicated for weight management or maintenance of healthy weight
- •Use of drugs or substances known to be inducers or inhibitors of P-glycoprotein (P-gp) within 28 days prior to dosing
- •Received any investigational drug within 3 months of the Screening Visit
- •History of coronavirus disease 2019 (COVID-19) infection within 14 days prior to the Screening Visit or close contact with a COVID-19 patient in the 14 days prior to the Screening Visit as reported by the participant and the participant's medical history
- •Presence of HIV antibody at the Screening Visit or within 90 days prior to the Screening Visit
- •Regularly consumes excessive amounts of alcohol, defined as > 3 glasses of alcoholic beverages per day
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy, that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
- •Female study participants who have a positive urine pregnancy test at the Screening Visit
- •Female study participants who are breastfeeding
- •Poor venous access based on the investigator's judgement
- •Unable to swallow capsules
- •Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration < 11.5 g/dL for males, < 10.5 g/dL for females) at the Screening Visit or any other condition known to interfere with interpretation of HbA1c measurement
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Dose Level 1: S-309309
Experimental
Participants will receive S-309309 (low dose) once daily for 24 weeks
干预措施: S-309309 (Drug)
Dose Level 2: S-309309
Experimental
Participants will receive S-309309 (middle dose) once daily for 24 weeks
干预措施: S-309309 (Drug)
Dose Level 3: S-309309
Experimental
Participants will receive S-309309 (high dose) once daily for 24 weeks
干预措施: S-309309 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline, Week 24
次要结局
- Percentage of Participants Achieving a Weight Loss of ≥ 5%(Baseline to Week 24)
- Percentage of Participants Achieving a Weight Loss of ≥ 10%(Baseline to Week 24)
- Percentage of Participants Achieving a Weight Loss of ≥ 15%(Baseline to Week 24)
- Percentage of Participants Achieving a Weight Loss of ≥ 20%(Baseline to Week 24)
- Change From Baseline in Waist Circumference(Baseline, Week 24)
- Change From Baseline in Hip/Waist Ratio(Baseline, Week 24)
- Change From Baseline in BMI(Baseline, Week 24)
- Change From Baseline in Leptin(Baseline, Week 24)
- Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG)(Baseline, Week 24)
- Change From Baseline in Cardiovascular Risk Factors(Baseline, Week 24)
- Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan(Baseline, Week 24)
- Change From Baseline in Glucose Metabolism Parameters as Assessed by Hemoglobin A1c or Glycosylated Hemoglobin (HbA1c)(Baseline, Week 24)
- Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan(Baseline, Week 24)
- Change From Baseline in Body Composition: Visceral Fat Mass as Assessed by DEXA scan(Baseline, Week 24)
- Plasma Concentration of S-309309(Up to 24 weeks)
- Change From Baseline in Adiponectin(Baseline, Week 24)
- Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)(Baseline, Week 24)
研究者
研究点 (48)
Loading locations...
相似试验
已完成
2 期
Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese ParticipantsOverweightNCT01749137Rhythm Pharmaceuticals, Inc.74
已完成
3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) PatientsDiarrheaHIV InfectionsNCT00002408Shaman Pharmaceuticals300
终止
2 期
A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.ObesityNCT007468247TM Pharma A/S192
已完成
3 期
Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)ObesityNCT00386061Sanofi1,507
已完成
2 期
Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)OverweightObesityBody WeightNCT00642993Merck Sharp & Dohme LLC401