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A Study of LY3305677 in Healthy Participants

Plain-language guide to NCT02972645: phase 1 randomized trial of Mazdutide, 66 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02972645
Phase
phase 1
Status
completed
Start
2016-12-05
Completion (planned or actual)
2017-07-14
Participants
66 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Mazdutide.

This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.

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

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 66 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: Overtly healthy as determined by medical history and physical examination. Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause. First generation Japanese participants or non-Japanese participants. Have a body weight of more than 50 kilograms (kg).

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: have participated within the last 3 months in a clinical trial involving an investigational product; have an abnormality in the 12-lead electrocardiogram (ecg) at screening and/or day -1; have undergone any form of bariatric surgery.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2016-12-05 with completion listed for 2017-07-14.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): 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 to Study Completion (approximately 16 weeks)).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Mazdutide in 66 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.

Our Notes on the Compound

Mazdutide: A dual GLP-1 and glucagon receptor agonist with approvals announced in China for weight management and type 2 diabetes.

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.