A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Mazdutide.

This trial is conducted in China.

It had two arms (groups): warfarin+atorvastatin+IBI362 (experimental) and metformin+digoxin+IBI362 (experimental).

The registry classes the interventions as drug.

Who Took Part

48 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male, age between 18 and 45 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 24 and 30 kg/m\^2 (both inclusive) and weight≥50kg.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: drug or alcohol abuse; have dysphagia or any history of gastrointestinal diseases that affect drug absorption; medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

How the Study Was Run

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

Each person switched between Mazdutide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Mazdutide study: the participants and staff both knew the treatment.

It started in 2023-04-06 with completion listed for 2023-08-18.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum observed metformin plasma concentration at steady state (time frame: up to 116 days). Area under the metformin plasma concentration-time curve (time frame: up to 116 days). Maximum observed warfarin plasma concentration at steady state (time frame: up to 116 days).

It also tracked 6 secondary outcomes, for example Actual adverse events, Terminal elimination half-life, time to maximum plasma concentration of IBI362, Incremental area under the INR (international normalised ratio) -curve of warfarin, Total apparent clearance of IBI362 and Apparent volume of distribution of IBI362.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Mazdutide in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.