Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity

What Was Tested

This registered phase 1 trial tested MariTide (Maridebart Cafraglutide).

It had 1 arm (groups): COC + Maridebart Cafraglutide (experimental).

Participants will receive COC orally and maridebart cafraglutide subcutaneously (SC).

The registry classes the interventions as drug.

Who Took Part

49 actual participants took part.

It was open to women only aged from 45 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria. Body mass index must be ≥ 25.0 and ≤ 38.0 kg/m\^2. Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening. Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening. Other inclusion criteria may apply.

The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: endocrine disorders that can cause obesity, such as cushing's syndrome; migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy; malignancy within the past 5 years, except nonmelanoma skin cancer.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label MariTide (Maridebart Cafraglutide) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-04-09 with completion listed for 2026-11-18.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum Observed Concentration (Cmax) of COC (time frame: Day 1 up to Day 89). Area Under the Concentration-time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of COC (time frame: Day 1 up to Day 89). AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC (time frame: Day 1 up to Day 89).

It also tracked 4 secondary outcomes, for example Plasma Concentrations of Maridebart Cafraglutide, Number of Participants with Treatment-emergent Adverse Events (TEAEs), Number of Participants with Serious Adverse Events (SAEs) and Number of Participants Who Develop Anti-maridebart Cafraglutide Antibodies.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of MariTide (Maridebart Cafraglutide) in 49 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, all human trials.