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A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity
Plain-language guide to NCT07310563: phase 1 randomized trial of MariTide (Maridebart Cafraglutide), 59 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07310563
- Phase
- phase 1
- Status
- completed
- Start
- 2024-12-10
- Completion (planned or actual)
- 2025-05-09
- Participants
- 59 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Overweight; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test MariTide (Maridebart Cafraglutide).
It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 59 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female participants, between 18 and 65 years of age. Body mass index \> 25 kg/m\^2.
The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: history or evidence of endocrine disorder; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; uncontrolled thyroid disease.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got MariTide (Maridebart Cafraglutide) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label MariTide (Maridebart Cafraglutide) study: the participants and staff both knew the treatment.
It started in 2024-12-10 with completion listed for 2025-05-09.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Maximum Observed Plasma Concentration (Cmax) of AMG 133 (time frame: Up to Day 120). Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133 (time frame: Up to Day 120). AUC from Time Zero to Infinity (AUCinf) of AMG 133 (time frame: Up to Day 120).
It also tracked 3 secondary outcomes, for example Number of Participants with Treatment-emergent Adverse Events (TEAEs), Number of Participants with Serious AEs (SAEs) and Number of Participants with Anti-AMG 133 Antibodies.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 59 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the MariTide (Maridebart Cafraglutide) compound page, all human trials.
Our Notes on the Compound
MariTide (Maridebart Cafraglutide): Amgen's once-monthly antibody-peptide conjugate that blocks GIP receptors and activates GLP-1 receptors, in phase 3 obesity trials. News and evidence page only.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.