RightFit
Not yet recruitingPhase 3

Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight

A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adults can give themselves maridebart cafraglutide at home using an autoinjector, a device that gives a shot under the skin. It is for adults with obesity, or adults who are overweight and have certain weight-related health problems.

The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure of weight compared with height, of 30 or higher; or a BMI of 27 to less than 30 with at least one of the health problems listed below.
  • For BMI 27 to less than 30: high blood pressure that is treated or measures 130 or higher for the top number, or 80 or higher for the bottom number.
  • For BMI 27 to less than 30: treated or previously diagnosed high cholesterol, high triglycerides (blood fats), or low HDL (good cholesterol).
  • For BMI 27 to less than 30: a history of obstructive sleep apnea (blocked breathing during sleep), heart or blood vessel disease, or fatty liver disease.
  • Have tried at least once to lose weight through diet and exercise without success.
  • Use birth control if female.
  • Be willing to follow study steps for the whole study.

Who can't join

  • Have obesity caused by another hormone disorder.
  • Had a weight change of more than 5 kilograms (about 11 pounds) in the past 90 days.
  • Have had or plan to have obesity treatment using surgery, a scope, or a device.
  • Have had cancer in the past 5 years.
  • Have type 1 or type 2 diabetes.
  • Have a history of chronic pancreatitis (long-term swelling of the pancreas), or acute pancreatitis (sudden swelling) in the past 180 days.
  • Have a personal or family history of medullary thyroid cancer, a type of thyroid cancer.
  • Have taken part in a maridebart cafraglutide study before.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m\^2), or BMI ≥ 27 to \< 30 kg/m\^2 with one of the following: * hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg * dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol. * history of obstructive sleep apnea * history of cardiovascular disease * history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease \[MASLD\] or metabolic dysfunction-associated steatohepatitis \[MASH\]) * At least 1 unsuccessful attempt at weight loss by diet and exercise. * Contraception for females. * Willingness to follow trial procedures for the duration of the trial. Exclusion Criteria: * Obesity induced by other endocrinologic disorders. * Change in body weight \> 5 kg within last 90 days. * Previous or planned surgical, endoscopic, or device-based treatment for obesity. * History of malignancy within the past 5 years. * Type 1 or Type 2 diabetes mellitus. * History of chronic pancreatitis or history of acute pancreatitis within last 180 days. * Family or personal history of medullary thyroid cancer. * Previous participation in a Maridebart Cafraglutide trial.

Study sites (1)

FL