∙ Disease Characteristics

• Have a BMI ≥30 kg/m2 or ≥27 kg/m2

‣ previously diagnosed with at least one obesity-related comorbidity:

• Have at least one self-reported unsuccessful dietary effort to lose body weight

• Meet Diagnostic and Statistical Manual (DSM)-5 criteria for Binge Eating Disorder (BED) as diagnosed by the Eating Disorder Examination interview and confirmed by binge-eating diaries that is moderate or greater in severity (4 or more episodes per week)

• Participant Characteristics

• Are 18 years of age or older

• Participants assigned female at birth: (participants assigned female at birth who are not of childbearing potential may participate and include those who are:

‣ infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation), congenital anomaly such as Mullerian agenesis

⁃ postmenopausal, defined as either

⁃ a female at least 40 years of age with an intact uterus, not on hormone therapy and who has cessation of menses for at least 1 year without an alternative medical cause; women in this category must test negative in pregnancy test prior to study entry OR

⁃ a female 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea OR

⁃ a female at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy

• Participants assigned female at birth of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:

⁃ test negative for pregnancy at Visit 1 based on a serum pregnancy test

⁃ and if sexually active, agree in writing to use 2 forms of effective contraception, where at least 1 form is highly effective, for the duration of the trial

⁃ not be breastfeeding

• Informed Consent

• Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent in accordance with local regulations

• In the investigator's opinion, are well-motivated, capable, and willing to:

‣ Learn how to self-inject study drug, as required for this protocol (persons with visual impairments or physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug)

⁃ Inject study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

⁃ Learn how to take oral capsules, be consistently able to swallow capsules, and willing to take oral capsules daily as required for this protocol

⁃ Follow study procedures for the duration of the study