Home self-administration of a weight-management medicine with an autoinjector in adults who are overweight or obese

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating a home-use autoinjector for subcutaneous doses of maridebart cafraglutide in adults with obesity or overweight. Eligible participants have a BMI of 30 or higher, or 27-29.9 with additional risk factors, and have previously tried diet and exercise without achieving meaningful weight loss. Participants will use the autoinjector to self-administer treatment at home, with study procedures followed for the duration of the trial. The study is sponsored by Amgen and sites are in Florida and California. Primary outcomes focus on the feasibility and safety of at-home administration, with secondary goals related to tolerability and adherence.

Why it matters

Who can join: the full rules

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.

Where it's running

• Apex Clinical Research
  San Diego, California, United States Recruiting
• Southern Clinical Research
  Miami, Florida, United States Recruiting
• Research Institute of South Florida
  Miami, Florida, United States Recruiting
• Clinical Neuroscience Solutions LLC
  Orlando, Florida, United States Recruiting
• Florida Institute for Clinical Research
  Orlando, Florida, United States Recruiting
• Charter Research - The Villages
  The Villages, Florida, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Monthly dose of PF-08653944 vs placebo in Chinese adults who are overweight or obese

  This study tests whether berobenatide (PF-08653944) given once a month helps adults in China lose weight compared with a placebo.

  Recruiting Phase 3 Pfizer · Hefei, Anhui and 5 other locations · NCT07874633

• FutureShape Family: a family-based weight-management program with semaglutide for children and parents

  This trial tests whether a family-centered program that combines a prescription medication (semaglutide) with lifestyle support and app-based coaching can help adults with obesity and their children who are overweight/obese.

  Recruiting Phase 4 University of Copenhagen · Copenhagen · NCT07872904

• Switching to Zenagamtide From Tirzepatide in Adults With Overweight or Obesity With or Without Type 2 Diabetes

  This study tests whether adults who are overweight or have obesity (with or without type 2 diabetes) can switch from tirzepatide to a new treatment called zenagamtide to find a tolerable dose.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07868354

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.