Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

What Was Tested

This registered phase 3 trial tested MariTide (Maridebart Cafraglutide).

Trial 20250197 is an extension of trial 20210181 (NCT06858839).

It had ten arms (groups): one (experimental), one (experimental), one (experimental), one (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

3200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Completed the parent trial (2010181). Completed week 72 visit in parent trial. Did not permanently discontinue trial intervention in parent trial. Randomized within 7 Days of week 72 visit in the parent trial.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: planned (during the trial) surgical, endoscopic, or device-based treatment for obesity; body mass index ≤ 18.5 kilograms per meter square (kg/m\^2); history of ischemic optic neuropathy.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this MariTide (Maridebart Cafraglutide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on MariTide (Maridebart Cafraglutide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-07-23 with completion listed for 2027-12-26.

It ran at 92 sites in United States (71), Australia (8), Japan (7), Canada (3) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Body Weight from Baseline of the Parent Trial (20210181) (time frame: Baseline of parent trial (20210181) to Week 48 of current trial). Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline of current trial up to 60 weeks).

It also tracked 11 secondary outcomes, for example Change from Baseline of the Parent Trial in Waist Circumference and Percent Change from Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of MariTide (Maridebart Cafraglutide) in 3200 people.

With 3200 participants it is a large trial for this field.

It is still 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.