Liraglutide 3.0mg/d for the Treatment of Binge Eating Disorder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Binge Episodes
研究概览
简要总结
The study is a 17-week, single-center, double-blind, parallel-group, randomized placebo controlled trial that will test the efficacy of liraglutide 3.0 mg/d as compared to placebo in reducing the number of binge episodes per week, achieving remission from binge episodes, and in changes in body weight, global BED symptom improvement, cognitive restraint of food intake, dietary disinhibition, perceived hunger, quality of life, and depressed mood at treatment end.
详细描述
All applicants will be initially screened by phone and/or electronically to determine whether they potentially meet eligibility criteria. Those who appear to meet eligibility criteria and remain interested in the trial will be scheduled for an in-person interview.
The in-person interview will be conducted by a psychologist or Masters' level staff member, who will obtain informed consent and evaluate subjects' behavioral eligibility (i.e., willingness and appropriateness to participate) using structured and semi-structured clinical interviews including: an examination of the applicants' BED symptoms, their mood, suicidality, and other general psychopathology. Participants will also be asked to complete questionnaires assessing eating behavior, demographic characteristics, frequency of specific eating behaviors related to loss of control, risk of substance dependence with the consumption of high fat/sugar foods, alexithymia, night eating syndrome, sleep patterns and quality, and attitudes towards food cravings.
Subjects who remain interested and pass this portion of the assessment will proceed to meet with the study physician or nurse practitioner, who will obtain a medical history and conduct a physical examination to determine medical eligibility. Subjects will also have an electrocardiogram (EKG), fasting blood test, and a urine pregnancy test (for females of child bearing age) to confirm eligibility.
Upon successful completion of the screening visit, subjects will be asked to eat as they normally would for 2 weeks. Once per week over these two weeks they will receive a brief survey through REDcap to assess their binge eating episodes for eligibility.
Subjects who continue to meet eligibility criteria assessed at the screening visit and during the run-in period will be scheduled for a randomization visit at the Center within 3 weeks of their screening.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Novo Nordisk's Clinical Services (CS) will label, package, and ship the labelled study drugs to the Penn's Investigational Drug Service (IDS). Dr. Rockwell from Penn's IDS service will generate the randomization code using a 1:1 randomization scheme of liraglutide and placebo. The first subject to meet the treatment criteria will be assigned the first number in the sequence; each subsequent subject to meet treatment criteria will be assigned the next number in the sequence. Unblinding of the treatment codes will occur after all data have been verified and deemed clean by the data managers and statistician, and right before analysis of the data occurs.
The code for a particular subject may be broken in a medical emergency if knowing the identity of the treatment allocation would influence the treatment of the subject or if demanded by the subject. Whenever a code is broken, the staff-member breaking the code will record the time, date and reason.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30 kg/m2 or BMI ≥ 27 - 29.9 kg/m² in the presence of at least one weight-related comorbid condition, such as binge eating disorder, hypertension, or dyslipidemia. There is no upper BMI limit for this trial.
- •Age ≥ 21 years and ≤ 70 years
- •Meet full DSM 5 criteria for BED
- •Recurrent episodes of binge eating characterized by both consuming an abnormally large amount of food in a short period of time compared with what others might eat in the same amount of time under the same or similar circumstances and experiencing a loss of control over eating during the episode.
- •These episodes feature at least 3 of the following:
- •i. consuming food more rapidly than normal; ii. eating until uncomfortably full; iii. consuming large amounts of food when not hungry; iv. consuming food alone due to embarrassment; v. feeling disgusted, depressed, or guilty after eating a large amount of food. c. Significant distress about the binge episodes is present. d. Binge episodes must occur, on average, at least once per week for 3 months.
- •All races and ethnicities are included
- •Eligible female subjects will be:
- •non-pregnant, evidenced by a negative urine dipstick pregnancy test
- •non-lactating
- •surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study
- •Ability to provide informed consent before any trial-related activities
- •Subjects must:
- •have a primary care provider (PCP) who is responsible for providing routine care
- •have reliable telephone or Internet service to communicate with study staff
- •understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
- •plan to remain in the Philadelphia area for the next 6 months or more
排除标准
- •Pregnant or nursing, or plans to become pregnant in the next 6 months, or not using adequate contraceptive measures
- •Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
- •Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg)
- •Type 1 diabetes
- •Type 2 diabetes
- •A combination of fasting glucose ≥ 126 mg/dl, combined with an HbA1c >6.5, will be used to indicate the presence of diabetes, an exclusion criterion
- •Recent history of cardiovascular disease (e.g., myocardial infarction or stroke within the past 6 months), congestive heart failure, or heart block greater than first degree
- •Clinically significant hepatic or renal disease
- •Thyroid disease, not controlled
- •History of malignancy (except for non-melanoma skin cancer) in past 5 years
- •The presence of current anorexia nervosa or bulimia nervosa
- •Current major depressive episode, active suicidal ideation, or lifetime history of suicide attempts. We will exclude participants who have a Patient Health Questionnaire-9 (PHQ-9) [31] score > 15, or a score of > 1 on the suicidal ideation item, as well as any risk of suicidality as measured by a score of 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)[32].
- •Psychiatric hospitalization within the past 6 months
- •Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
- •Diagnosis current or past psychosis
- •Use in past 3 months of medications known to treat BED (such as lisdexamfetamine), induce significant weight loss (i.e., prescription weight loss medications), or induce weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- •Currently receiving behavioral or pharmacological treatment for BED
- •Loss of ≥ 10 lb of body weight within the past 3 months
- •Known or suspected allergy to trial medication(s), excipients, or related products
- •Hypersensitivity to liraglutide or any product components
- •The receipt of any investigational drug within 6 months prior to this trial
- •Previous participation in this trial (e.g., randomized and failed to participate)
- •History of pancreatitis
- •History of gastrointestinal surgery (unless it was an adjustable gastric band that has been removed).
研究组 & 干预措施
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
干预措施: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml (Drug)
Placebo
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Binge Episodes
时间窗: baseline and 17 weeks (or last observation carried forward)
Change in objective binge episodes per week from randomization (week 0) to study end (week 17)
次要结局
- Change in Body Weight(baseline and 17 weeks (or last observation carried forward))
- Remission From Binge-eating(13 to 17 weeks)
- Assessment of Improvement of Binge Eating Symptoms(week 17 (or last observation carried forward))
研究者
Kelly Allison
Associate Professor
University of Pennsylvania