People with Obesity often find it difficult to lose weight and keep it off. This study is testing a new medication called Maridebart Cafraglutide, which is given as a small injection under the skin (subcutaneous use). Some participants will receive the medication while others will receive a placebo, which looks the same but does not contain the active drug.
The purpose of the study is to see how the medication works over a long period to reduce body weight and to check that it is safe and well tolerated. Participants will receive regular injections and will visit the clinic at set times for simple checks such as weight, a measurement around the waist (waist circumference), and short questionnaires about daily activities and overall well‑being. Any side effects (called adverse events) will be recorded, and the study will continue for several months to see how much weight is lost and whether the loss is maintained.
1baseline assessments
after joining the study, you will complete initial measurements that include body weight, waist circumference, and a short questionnaire about quality of life.
blood samples will be taken to evaluate your health status before any medication is given.
2randomization and start of medication
based on a computer‑generated assignment, you will receive either maridebart cafraglutide (the test drug) or a matching placebo.
the medication is supplied as a solution for injection that is administered under the skin (subcutaneous use).
3injection visits
you will visit the study site according to the schedule defined in the protocol to receive an injection of the assigned product.
each injection contains the dose listed in the protocol (0 mg) and is given as a subcutaneous injection.
the frequency of injections follows the study schedule and continues for the entire extension period, which lasts until the trial end date (approximately 17 months).
4regular safety checks
at each visit, health professionals will ask about any new symptoms or side effects and will record any adverse events.
additional blood tests may be performed to monitor safety.
5weight and waist monitoring
your body weight and waist circumference will be measured at planned intervals to track changes over time.
the study also records whether you achieve specific weight‑loss targets (5 %, 10 %, 15 %, or 20 % reduction from the baseline of the parent trial).
6final evaluation
at the end of the extension period, a final set of measurements, questionnaires, and safety assessments will be performed.
the data collected will be used to evaluate the long‑term efficacy, safety, and tolerability of maridebart cafraglutide.
Who Can Join the Study?
Sign an informed consent form, which shows you understand the study and agree to follow its rules.
Have completed the earlier related study (called the “parent trial”) and not have stopped the study medication permanently.
Be assigned to a study group (the process is called randomization) within 7 days after the week‑72 visit of the parent trial.
Agree to use a birth‑control method that meets the study’s requirements during treatment and for 16 weeks after the last dose of the study drug.
Be either male or female, as the trial includes participants of both genders.
Be within the adult age range specified by the study.
Who Cannot Join the Study?
Planned surgery, endoscopy, or use of a medical device to treat obesity during the study.
Any other serious health problem (such as drug or alcohol abuse, eating disorders, or other diseases) that the doctor believes could make participation unsafe.
Being pregnant (confirmed with a positive test) or breastfeeding, or planning to become pregnant or breastfeed while taking the study drug and for 16 weeks after the last dose.
Having a major surgical operation planned during the study period (minor surgeries that do not need full anesthesia may be allowed at the doctor’s discretion).
Being a study site staff member or an immediate family member (spouse, parent, child, or sibling) of a staff member.
Having a body mass index (BMI) of 18.5 kg/m² or lower (BMI is a measure of weight relative to height).
Having a known allergy or sensitivity to any ingredient in the study medication.
Having a history of ischemic optic neuropathy (damage to the eye’s optic nerve caused by poor blood flow).
Having any cancer diagnosed during the earlier trial, except for certain skin cancers and early‑stage cancers that were treated with curative intent (non‑melanoma skin cancer, ductal carcinoma in situ of the breast, carcinoma in situ of the cervix, or carcinoma in situ of the prostate).
Being newly found to have multiple endocrine neoplasia syndrome type 2 or having a first‑degree relative (parent, sibling, or child) with medullary thyroid carcinoma (MTC) (a specific type of thyroid cancer).
Scoring 15 or higher on the Patient Health Questionnaire‑9 (PHQ‑9) at the week‑72 visit before randomization (the PHQ‑9 measures how severe depression symptoms are).
Having suicidal thoughts classified as category 4 or 5, or any suicidal behavior on the Columbia‑Suicide Severity Rating Scale (C‑SSRS) since the last visit at week 72 before randomization.
Being judged by the doctor as unlikely to complete all required study visits, procedures, and rules.
Maridebart Cafraglutide is a medication given as a liquid that is injected under the skin. In this trial it is being tested to see how well it helps people who are overweight or have obesity lose weight over a long period. Researchers are also checking that it is safe and that people can tolerate it without serious side effects. The drug is studied in a double‑blind, randomized design, meaning neither the participants nor the doctors know who receives the medication, which helps provide reliable results.
Chronic Weight Management – Chronic weight management refers to the long‑term condition of maintaining excess body weight. Over time, individuals may experience a gradual increase in body mass due to persistent energy imbalance. The excess weight can lead to enlargement of waist circumference and may become more difficult to reduce as the body adapts. Weight tends to fluctuate with lifestyle changes, but without sustained interventions it often returns toward baseline. The condition can persist for many years, influencing physical function and quality of life.
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