Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAmgen

About this trial

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants, of any race, between 18 and 60 years of age (inclusive).

Females must not be pregnant or lactating.

Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m²).

Have a stable body weight within 3 months before screening.

Disqualifiers

History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.

History or evidence of endocrine disorder that can cause obesity.

History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (> 2 x upper limit of normal [ULN]) at screening or check-in, or fasting serum triglyceride level of > 500 milligrams per deciliter (mg/dL) at screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maridebart Cafraglutide

    Drug

    Maridebart cafraglutide will be administered via SC injection.

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Maridebart Cafraglutide (Test)Experimental treatment 1 intervention
Group B: Maridebart Cafraglutide (Reference)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide

Time frame
Up to Day 120
2

Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide

Time frame
Up to Day 120
3

Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

Time frame
Up to Day 120

Secondary outcomes

1

Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

Time frame
Up to Day 120
2

Number of Participants With Anti-Maridebart Cafraglutide Antibodies

Time frame
Up to Day 120

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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