BINGE EATING DISORDER · White paper
Binge Eating Disorder Clinical Trials
Approved therapies, the pivotal-trial endpoints they were judged on, the magnitude of benefit — and the drugs that failed their endpoints, and why.
Indication overview
About binge eating disorder — and why its trials are hard
Binge Eating Disorder (BED) is the most prevalent eating disorder, defined by recurrent episodes of eating large amounts of food with a sense of loss of control, without the compensatory behaviors seen in bulimia. Formally recognized in DSM-5 in 2013 and coded 6B82 in ICD-11, it affects roughly 2-4% of the population, disproportionately women, and is linked to obesity, metabolic disease, and depression or anxiety. Lisdexamfetamine (Vyvanse) is the only agent FDA-approved specifically for moderate-to-severe BED, approved in 2015 on the strength of reductions in binge days per week and relapse prevention. Topiramate, SSRIs such as sertraline and fluoxetine, and naltrexone/bupropion are used off-label. Trials are challenged by high placebo response, patient heterogeneity, and reliance on subjective, self-reported binge counts. Reduction in binge-eating frequency is the pivotal endpoint, supported by CGI, Y-BOCS-BE, weight, and psychological measures. Failed candidates including dasotraline, the orexin antagonist ACT-539313, and cannabinoid antagonists taranabant and rimonabant illustrate persistent efficacy and safety hurdles.
Approved therapies & pivotal evidence
What's been approved — and by how much it moved the endpoint
| Drug (brand) | Approved | Setting | Pivotal trial | Primary endpoint | Magnitude of benefit |
|---|---|---|---|---|---|
| Lisdexamfetamine (Vyvanse) | 2015 | Only agent FDA-approved specifically for moderate-to-severe BED in adults; stimulant prodrug | Studies 11 & 12 (NCT01718483 program); Study 13 randomized withdrawal | Change in binge days per week; time to relapse | Placebo-subtracted reduction of ~1.35-1.66 binge days/week; relapse 5% vs 42% at 26 weeks |
| Topiramate (Topamax) | 1996 | Antiepileptic used off-label for BED; modulates GABA/glutamate (not BED-specific approval) | NCT00044906 | Reduction in binge episodes | ~50% reduction in binge episodes vs ~20% on placebo (p<0.05) |
| Naltrexone/bupropion (Contrave) | 2014 | Weight-management combination used off-label for BED; opioid antagonist plus dopamine modulator (approval is for chronic weight management) | NCT01122382 | Reduction in binge frequency; weight loss | ~55% binge-frequency reduction with ~6% weight loss over 16 weeks (p<0.01) |
| Sertraline (Zoloft) | 1991 | SSRI used off-label to reduce binge behavior and treat comorbid depression/anxiety (approval is for depression/anxiety indications) | NCT00529024 | Binge frequency and depression/anxiety scores | ~40% decrease in binge frequency and ~30% reduction in mood/anxiety scores (p<0.05) |
| Liraglutide (Saxenda) | 2014 | GLP-1 receptor agonist for weight management, studied off-label in BED (Saxenda approved 2014; not BED-specific) | NCT02278952 | Binge episode reduction; weight loss | ~60% decrease in binge episodes with ~8% weight loss over 24 weeks (p<0.01) |
Where trials have failed
Drugs that missed their endpoint — and what contributed
The most instructive lessons in binge eating disorder development come from programmes that failed the endpoint that mattered.
| Drug / trial | Endpoint outcome | What contributed |
|---|---|---|
| Dasotraline — NCT02564588 | Development discontinued for insufficient efficacy and safety concerns (insomnia, anxiety) | Long half-life dopamine/norepinephrine reuptake inhibitor with a poor benefit-tolerability balance |
| ACT-539313 (orexin-1 receptor antagonist) — NCT03688830 | Failed to meet the primary endpoint of reducing binge-eating episodes, though safety was acceptable | Preclinical efficacy did not translate to clinical benefit in BED |
| Rimonabant — Cannabinoid CB1 antagonist program | Withdrawn/terminated due to serious psychiatric side effects including depression and suicidality | CB1 antagonism carries unacceptable neuropsychiatric risk (class effect also seen with taranabant) |
Choosing the right endpoint
Primary endpoints that matter in binge eating disorder trials
- Reduction in binge-eating days/episodes per week — Pivotal primary endpoint; typically self-reported via daily binge diary, vulnerable to recall bias
- Time to relapse (randomized withdrawal) — Maintenance endpoint demonstrating durability of effect, central to lisdexamfetamine's approval
- CGI-S / Y-BOCS-BE — Clinician global severity and obsessive-compulsive-style binge measures used as key secondaries
- Weight and metabolic markers — Capture comorbid obesity-related benefit; must be distinguished from binge cessation effects
- Psychological and quality-of-life measures — Depression/anxiety scales and BED-specific QoL instruments assess functional and emotional impact
How iNGENū runs binge eating disorder trials
Physician-led design, built for FDA submission
Endpoint & biomarker strategy
Board-certified specialists design endpoints and patient selection aligned to current FDA guidance for this indication.
FDA-ready data
Built to ICH-GCP and 21 CFR 312.120, with direct FDA submission — data accepted by the FDA, EMA and MHRA.
Faster, lower-cost delivery
~4-week ethics via the TGA CTN scheme, up to 43.5% R&D rebate, and 80–90% below US CRO cost.
The full white paper: approved-product analyses, pivotal endpoints and trial-design strategy. Open-access · no sign-in.
Frequently asked questions
Binge Eating Disorder clinical trials — FAQs
Which drug is FDA-approved specifically for binge eating disorder?
What is the primary endpoint in BED clinical trials?
Why do BED trials often fail?
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