Binge Eating Liraglutide Intervention

NCT03279731 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 827450
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Binge-Eating Disorder

Keywords

eating disorder, pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• Binge Episodes

  Change in objective binge episodes per week from randomization (week 0) to study end (week 17)

  baseline and 17 weeks (or last observation carried forward)

Secondary Outcomes (3)

• Remission From Binge-eating

  13 to 17 weeks

• Assessment of Improvement of Binge Eating Symptoms

  week 17 (or last observation carried forward)

• Change in Body Weight

  baseline and 17 weeks (or last observation carried forward)

Study Arms (2)

Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

ACTIVE COMPARATOR

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.

Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml DRUG

subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). 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 (Saxenda) 6Mg/Ml Inj Pen 3Ml

Placebo DRUG

subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Kelly Allison: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University of Pennyslvania

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Error by Investigational Drug Service - randomization key interpreted incorrectly at n=21 n= 6 had 2+ consecutive boxes of same agent and were retained in analyses (data censored after first switch); 6 received same agent consistently; n=9 censored

Results Point of Contact

• Title: Kelly C. Allison, PhD
• Organization: Perelman School of Medicine at the University of Pennsylvania

kca@pennmedicine.upenn.edu

2158982823

Study Officials

• Kelly C Allison, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-center, double-blind, randomized placebo-controlled trial with parallel groups.

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 12, 2017
• Study Start: September 29, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 1, 2019
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)