Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder

Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder

Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the treatment of adults with moderate to severe binge eating disorder

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Drug: ACT-539313; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Southern California Research
    • Encino, California, United States, 91316
      • Wr-Pri, Llc
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network (CNS)
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Connecticut Clinical Research - Cromwell
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neurosciences Solutions
    • North Miami, Florida, United States, 33161
      • Behavioral Clinical Research
    • Orlando, Florida, United States, 31801
      • Clinical NeuroScience Solutions Inc
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuorTrials Research Inc
    • Marietta, Georgia, United States, 30060
      • Psych Atlanta P.C.
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Collective Medical Research
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Harvard Medical School - McLean Hospital
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials, Inc
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates dba Midwest Research Group
  • Nevada
    • Las Vegas, Nevada, United States, 89194
      • M3 Wake Research
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03081
      • ActivMed Practices & Research, Inc.
    • Portsmouth, New Hampshire, United States, 03081
      • ActivMed Practices & Research
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine PLLC
    • New York, New York, United States, 10128
      • The Medical Research Network
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45221
      • Patient Priority Clinical Sites
    • Mason, Ohio, United States, 45040
      • University of Cincinnati College of Medicine - Lindner Center of HOPE
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company
  • Oregon
    • Portland, Oregon, United States, 97214
      • Oregon Center For Clinical Inv.
    • Salem, Oregon, United States, 97304
      • Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc. (CTT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Criteria assessed at Visit 1:

• Signed and dated informed consent form prior to any study-mandated procedure.
• Male or female study participants aged 18 to 55 years at the time of signing the informed consent form.
• Binge-eating disorder (BED) in accordance with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria diagnosed using the Structured Clinical Interview for DSM-5 (SCID-5).
• Self-reported BED severity of at least moderate level, defined as at least 4 BE episodes per week, on average, for a duration of at least 6 months.
• BED in accordance with Eating Disorder Examination Questionnaire (EDE-Q).
• Clinical Global Impression of Severity scale (CGI-S) score of ≥ 4.
• For women of childbearing potential (WOCBP): Negative serum pregnancy test at Visit 1; agreement to undertake monthly urine or serum pregnancy tests during the study and up to the EOS visit; agreement to use an acceptable contraceptive method.

Criteria assessed at Visit 2:

• Reporting ≥3 BE days for each of the 2 weeks prior to randomization as documented in the participant's BE diary and with BE diary entries completed for at least 6 days per week during this 2-week period (between Visit 1 and 2).
• CGI-S score of ≥ 4.
• For WOCBP: negative urine pregnancy test.

Exclusion Criteria:

Criteria assessed at Visit 1:

• BMI < 18.0 kg/m² or > 45 kg/m².
• Any acute or chronic-persistent psychiatric disorder other than BED diagnosed in the past, including anorexia nervosa, bulimia, psychotic disorders, bipolar disorder, hypomania, or dementia, as defined by the DSM-5 criteria or by the Mini International Neuropsychiatric Interview (MINI©).
• Use of any medications for the treatment of BED (including lisdexamfetamine [Vyvanse®]), any other eating disorder, obesity, or weight gain, or any other medication that could result in weight gain or weight loss, including over-the-counter and herbal products, within 3 months prior to Screening.
• Any clinically unstable medical condition, significant medical disorder or acute illness that, in the investigator's opinion, could interfere with the participants ability to comply with study assessments or abide by study restrictions.

Criteria assessed at Visit 1 and Visit 2

• HAMD-17 score ≥ 17 points at Visit 1 and/or Visit 2.

• Any of the following conditions related to suicidality:

  1. Participant is considered to have a suicide risk in the investigator's opinion or has a previous history of suicide attempt within the past 12 months.
  2. Participant answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS© assessment at Screening (in the past month). Participants who answer "yes" to this question must be referred to the investigator for follow-up evaluation.
• Female participants: pregnant, lactating or planning to become pregnant during the projected course of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
Experimental: 100 mg twice daily (b.i.d.) ACT-539313	Drug: ACT-539313; ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week	BE days per week is defined as the number of diary days with at least one confirmed BE episode during the applicable 14-day time interval divided by the total number of diary days, times 7.	From baseline to Week 12; duration approx. 3.5 months

Other Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse events (TEAEs)	From the start of study treatment administration up to the End-of-Study (EOS); duration approx. 3.5 months
Treatment-emergent serious AEs (SAEs)	From the start of study treatment administration up to the End-of-Study (EOS); duration approx. 3.5 months

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: ID-082A201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No