A Study of Multiple Doses of LY3305677 in Healthy Participants

What Was Tested

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

This study will last approximately 17 weeks not including screening.

Screening is required within 4 weeks prior to start of the study.

It had two arms (groups): LY3305677 (experimental) and Placebo (placebo comparator).

Saline solution administered by SC injection.

The registry classes the interventions as drug.

Who Took Part

56 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Are overtly healthy males or females, as determined by medical history and physical examination. Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause. Have a body weight of more than 54 kilograms (kg).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: currently enrolled in a clinical study or have participated in a study within the past 3 months; have an abnormality in the 12-lead electrocardiogram (ecg) at screening; have history of pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Mazdutide and who got the comparison, which limits bias.

The Mazdutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-10-27 with completion listed for 2018-08-03.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through 115 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Mazdutide in 56 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.