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

ConditionsObesityOverweight
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Maridebart cafraglutide

    Drug

    Administered subcutaneously.

  • Autoinjector

    Device

    The AI will be used by participants to self-administer SC doses of maridebart cafraglutide.

Treatment groups

230 Participants
are divided into 1 treatment group
Group A: Maridebart cafraglutideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration

Time frame
Weeks 12, 16, and 20
2

Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration

Time frame
Weeks 12, 16, and 20

Secondary outcomes

1

Number of Participants Who Experience Device-related Adverse Events

Time frame
Up To 37 weeks
2

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
3

Plasma Concentration of Maridebart Cafraglutide at Week 24

Time frame
Week 24
4

Percent Change From Baseline in Body Weight at Week 24

Time frame
Baseline and Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: