Is NCT06847399 recruiting in Baltimore, MD?

Yes, NCT06847399 is currently recruiting participants at its Baltimore, MD location. This obesity and overweight clinical trial is actively enrolling qualified participants.

How do I join the obesity and overweight clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Obesity and Overweight Clinical Trial in Baltimore, MD

About This Obesity and Overweight Study in Baltimore

The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide against placebo and lisdexamfetamine dimesylate. All participants will receive guided self-help cognitive behavioral therapy.

Sponsor: Johns Hopkins University

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

Medical Conditions Eating disorder-related

Current diagnosis of bulimia nervosa or anorexia nervosa Diabetes-related

Have type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma

Have laboratory evidence diagnostic of diabetes mellitus during screening, including an HbA1c ≥6.5% or fasting glucose \>126 mg/dL Obesity-related:

Have a self-reported change in body weight \>5 kg within 3 months prior to screening

Have a prior or planned surgical treatment for obesity (excluding lap-band if removed \>6 months prior to screening or liposuction or abdominoplasty if performed \>1 year prior to screening)

Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal bypass sleeve) Other medical

Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2

Known serious hypersensitivity to tirzepatide or lisdexamfetamine dimesylate or any of the excipients in the medications

Have severe gastrointestinal disease

Have known clinically significant renal impairment

Have uncontrolled medical conditions or contraindications to tirzepatide or lisdexamfetamine dimesylate

Have personal or family history of cardiovascular disease that could increase vulnerability to sympathomimetic effects of psychostimulants

Have a history of suspected substance abuse within the past 5 years

Have a lifetime history of psychostimulant abuse and/or dependence

Have glaucoma

Have had a history of chronic or acute pancreatitis

Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome)

Have a current diagnosis of attention-deficit/hyperactivity disorder

Have a history of significant active or unstable Major Depressive Disorder (MDD; within the last 2 years) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, psychosis, mania, hypomania, or other serious mood or anxiety disorder) Note: Patients with MDD or generalized anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if not on excluded medications

Have a Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at Visit 1 or 2, prior to randomization

Have any lifetime history of a suicide attempt

Individual is considered a suicide risk in the opinion of the investigator; or endorsement of current, active suicidal ideation at screening or randomization. On the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visits 1 or 2, prior to randomization:

a "yes" answer to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or

a "yes" answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS or

a "yes" answer to any of the suicide-related behaviors (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Act or Behavior) on the "Suicidal Behavior" portion of the C-SSRS and

the ideation or behavior occurred within the past month

Have taken monoamine oxidate inhibitors (MAOI), or within 14 days of stopping MAOIs

Have uncontrolled hypertension (SBP above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)

Have any of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina

Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years

History of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, Parkinson's disease, or intracranial lesions

Participant has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place the participant at increased vulnerability to the sympathomimetic effects of a stimulant medication

Have a history of any other condition that, in the opinion of the investigator, may preclude the participant from following and completing the protocol Prior/Concomitant Therapy

Are receiving concurrent treatment for eating or weight disorders

Use of a psychostimulant within the past 6 months

Have taken within 3 months prior to screening, medications (prescribed or over-the counter) intended to promote weight loss. Examples include, but are not limited to

Saxenda® (liraglutide 3.0 mg)

Xenical®/Alli® (orlistat)

Meridia® (sibutramine)

Adipex® (phentermine)

BELVIQ® (lorcaserin)

Qsymia® (phentermine/topiramate combination)

Contrave® (naltrexone/bupropion)

Ozempic or Wegovy (semaglutide)

Mounjaro or Zepbound (tirzepatide)

Rybelsus (semaglutide) Prior/Concurrent Clinical Study Experience

Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT06847399) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obesity and Overweight Treatment Options in Baltimore, MD

If you're searching for obesity and overweight treatment options in Baltimore, MD, this clinical trial (NCT06847399) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obesity and overweight specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obesity and overweight clinical trials near you to find additional studies recruiting in your area.

Obesity and Overweight Clinical Trial in Baltimore, MD

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