NCT06517797尚未招募2 期
Phase IIb Placebo-Controlled Double-Blind Randomized Parallel Groups Study to Determine the Efficacy and Safety of S1B-509 for Weight Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 210
- 主要终点
- Per cent weight change
研究概览
简要总结
This is a study to test whether S1B-509 given orally daily helps people with overweight or obesity to lose more weight than with placebo over a year.
详细描述
This trial is to determine proof of concept for S1B-509 vs. placebo and to define a suitable dose escalation scheme and range for S1B-509 regarding safety, tolerability, and efficacy. The treatments will be given along with dietary advice and food intake monitoring. Change in body weight and in measures relating to obesity and its complications such as diabetes will be measured from baseline to week 48. Safety will be determined from adverse event reports, vital signs, routine laboratory tests, and mental health screeners.
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)
盲法说明
tablets of one of the actives and capsules of the other active matched to placebo tablets and capsules
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
- •Body mass index (BMI) ≥ 27 kg/m2 with significant comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia, sleep apnea, cardiovascular disease
- •Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
- •Visceral fat area ≥ 100 cm2
- •Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study.
- •Side effects from any continuing concomitant medications must be mild and stable or nil.
- •Females: not pregnant or lactating for six months; using medically reliable contraception, i.e., diaphragm or (male or female) condom and spermicide, IUD, tubal sterilization, hormonal contraception (oral, vaginal, or implant), or (if the investigator finds the patient credibly monogamous) vasectomy of male partner.
- •Gives informed consent for and is willing to undergo all of the scheduled evaluations.
- •Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations.
排除标准
- •Use of pharmacologically active weight-loss medications, glucagon-like peptide-1 (GLP-1) agonists or sodium-glucose co-transporter 2 (SGLT2) inhibitors, within 3 months of screening, or between screening and randomization.
- •Use of alpha glucosidase inhibitors within 3 months of Visit 1, or between screening and randomization.
- •Bariatric surgery
- •Lack of compliance with lifestyle intervention (defined as weight gain during 4-week Screening/run-in or with study medication (defined as < 80% study drug intake in more than one 4-week period
- •History of ketoacidosis, lactic acidosis, or hyperosmolar coma, or any of these occurring between Visit 1 and 2/randomization
- •Diabetics with HbA1c levels over 10 percent or fasting glucose levels greater than or equal to 270 mg/dl.
- •Symptomatic infection in the 4 weeks prior to screening or randomization.
- •Gastro-intestinal (GI) disorders associated with chronic diarrhea.
- •Congestive heart failure, New York Heart Association (NYHA) class III or IV
- •Body dysmorphic disorder or compulsive eating disorder
- •Chronic conditions that may in the investigator's judgment be expected to be unstable and affect overall health are not allowed. Examples: gastrointestinal bleeding in prior 6 months, diabetes mellitus with HB A1C >8.9, asthma not well controlled with treatment once or twice daily, current Major Depressive Disorder or recurrence of MDD off treatment for at least 2 months, anxiety disorder severe enough to prevent employment, severe sleep apnea, history within the prior year of suicidality or drug abuse, history of active breast, cervical, uterine, ovarian or other systemic cancer within the prior 24 months.
- •Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs
- •Takes any sex hormone other than an approved hormonal contraceptive
- •Takes an antiepileptic/mood stabilizer, antipsychotic, antidepressant, anxiolytic, or hypnotic drug
- •Drinks more than 7 alcoholic drinks per week (12-oz beer, 4-oz wine, 1 ½ oz liquor etc)
- •Uses marijuana more than once a week
- •History of seizures as an adult or use of antiepileptic medication
- •Long QT syndrome (QTc <=480 msec), other significant cardiovascular disease (hypertension controlled with one medication is acceptable)
- •Moderate or severe dysfunction of the liver (any LFT >=3x ULN) or renal dysfunction (BUN > 30 or Cr >2.0)
- •Uses sedating antihistamines or prescription sedatives daily
- •History of blood clots or abnormal bleeding tendencies, including daily use of medications adversely affecting coagulation, e.g., NSAIDs, systemic corticosteroids, or >81 mg aspirin daily.
研究组 & 干预措施
S1B-509 (proprietary combination of trazodone and bupropion) low dose
Experimental
Simultaneous oral dosing once daily with two to four extended-release tablets or capsules of S1B-509, for 48 weeks
干预措施: S1B-509 low dose (Drug)
Placebo
Placebo Comparator
Simultaneous oral dosing once daily with two to four placebos, for 48 weeks
干预措施: Placebo (Drug)
S1B-509 (proprietary combination of trazodone and bupropion) high dose
Experimental
twice the dose of "S1B-509 low dose"
干预措施: S1B-509 High Dose (Drug)
结局指标
主要结局
Per cent weight change
时间窗: 48 weeks
100 (Weight at follow-up) - (weight at baseline)/(weight at baseline)
Proportion losing at least 5% body weight
时间窗: 48 weeks
(number of subjects (no. ss) per group losing at least 5% body weight)/(total no. ss/group
次要结局
- Proportion losing 10%(48 weeks)
- Waist circumference(48 weeks)
- Proportion losing 15%(48 weeks)
- Change in Hemoglobin A1c(48 weeks)
- Edmonton Obesity Staging System(4 weeks)
- Change in Female Sexual Function Index, Female(4 weeks)
- Change in systolic blood pressure(48 weeks)
- Change in diastolic blood pressure(48 weeks)
- Change in Personal Health Questionnaire, 9-item version(48 weeks)
- Adverse events(4 weeks)
- Change in Columbia suicidality screener(48 weeks)
- Change in International Index of Erectile Function, 5-item version(4 weeks)
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