Phase 2 Eating Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People with a BMI of 30 or higher, or a BMI of 27 or higher if they have already been diagnosed with at least one health condition related to their weight
• People who report having tried and failed at least one diet to lose weight
• People who have been formally diagnosed with Binge Eating Disorder (BED) of moderate or greater severity, meaning they have 4 or more binge eating episodes per week, confirmed through a structured interview and eating diaries
• People aged 18 or older
• People assigned female at birth who are not able to become pregnant — for example, due to surgical sterilisation (such as hysterectomy, removal of both ovaries, or tubal ligation), a congenital condition affecting fertility, or being postmenopausal (confirm with trial site for specific age and menopause definitions that apply)
• People assigned female at birth who could become pregnant must test negative for pregnancy at the first visit, must not be breastfeeding, and if sexually active, must agree in writing to use 2 forms of effective contraception (at least one of which is highly effective) for the entire duration of the trial
• People who are willing and able to give written informed consent and follow all study procedures for the duration of the trial
• People who are willing to learn to self-inject the study drug, or who can arrange for a trained person to do the injections if they have a visual impairment or physical limitation
• People who are able to swallow capsules and are willing to take oral capsules daily as required

Who may not be able to join:

• People with a current diagnosis of bulimia nervosa or anorexia nervosa
• People with Type 1 or Type 2 diabetes, a history of diabetic ketoacidosis, or a hyperosmolar state or coma
• People whose blood test results during screening indicate diabetes — for example, an HbA1c of 6.5% or higher, or a fasting blood sugar above 126 mg/dL
• People whose body weight has changed by more than 5 kg (about 11 pounds) in the 3 months before screening
• People who have previously had weight-loss surgery or are planning to, with limited exceptions for certain procedures performed well before the trial (confirm with trial site)
• People who have had, or are planning to have, device-based treatments for obesity (such as an intragastric balloon or similar), or who have had such a device removed within the last 6 months
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related hormonal condition called Multiple Endocrine Neoplasia type 2
• People with a known serious allergy to either of the study medications (tirzepatide or lisdexamfetamine dimesylate) or their ingredients
• People with severe digestive or gastrointestinal disease
• People with known significant kidney problems
• People with medical conditions that are uncontrolled or that are known to be incompatible with either of the study medications
• People with a personal or family history of heart or cardiovascular disease that could make stimulant-type medication more risky for them
• People with a suspected history of substance misuse within the past 5 years, or any lifetime history of misuse of or dependence on stimulant medications
• People with glaucoma (a condition affecting eye pressure)
• People with a history of pancreatitis (inflammation of the pancreas), either chronic or acute
• People whose obesity is caused by another hormonal or genetic condition, such as Cushing's Syndrome, Prader-Willi Syndrome, or a specific genetic receptor deficiency
• People with a current diagnosis of ADHD (attention-deficit/hyperactivity disorder)
• People with a history of significant or unstable major depression in the past 2 years, or other serious psychiatric conditions such as schizophrenia, bipolar disorder, psychosis, or serious mood or anxiety disorders (note: people with stable major depression or generalised anxiety disorder may be considered in some cases, at the investigator's discretion, if not on excluded medications — confirm with trial site)
• People with a depression questionnaire score (PHQ-9) of 15 or more at the screening visits before being assigned to a treatment group
• People with any lifetime history of a suicide attempt
• People considered by the investigator to be at risk of suicide, or who report active thoughts of suicide at screening or at the point of being assigned to a treatment group, based on a specific suicide risk assessment tool (C-SSRS), where certain responses indicating intent or planning occurred within the past month
• People currently taking monoamine oxidase inhibitor (MAOI) medications, or who have stopped taking them within the past 14 days
• People with uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or above, and/or diastolic blood pressure of 100 mmHg or above)
• People who have had a heart attack, stroke, or unstable chest pain within the 3 months before being assigned to a treatment group
• People with an active or untreated cancer, or who have been in remission from a significant cancer for less than 5 years (certain early-stage skin or cervical cancers may be exceptions — confirm with trial site)
• People with a history of seizures (other than childhood febrile seizures), tic disorders, Tourette's Disorder (personal or family history), serious neurological disease, significant head trauma, dementia, Parkinson's disease, or growths inside the skull
• People with known heart disease, serious heart rhythm problems, coronary artery disease, structural heart abnormalities, or other serious heart conditions that could increase the risks of taking stimulant medication
• People with any other condition that, in the investigator's opinion, would prevent them from safely completing the trial
• People currently receiving other treatment for an eating disorder or for weight management
• People who have used a stimulant medication within the past 6 months
• People who have taken prescribed or over-the-counter weight-loss medications within the 3 months before screening — examples include liraglutide, orlistat, sibutramine, phentermine, lorcaserin, phentermine/topiramate, naltrexone/bupropion, semaglutide, or tirzepatide
• People currently enrolled in another clinical trial involving an investigational treatment that is not compatible with this study

Important: Always verify eligibility with the trial site directly before applying.