A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

What Was Tested

This registered phase 1 trial tested Retatrutide.

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese.

The safety and tolerability of LY3437943 when administered with COC will also be evaluated.

This study will last up to approximately 29 weeks for each participant.

It had 1 arm (groups): LY3437943 + Combined Oral Contraceptive (COC) (experimental).

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

The registry classes the interventions as drug.

Who Took Part

46 actual participants took part.

It was open to women only aged from 40 years up to 60 years.

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

Examples of who could join: Postmenopausal female participants. Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²).

The full record lists 2 inclusion and 18 exclusion criteria; among the exclusions: have an unstable disease or a disease constituting a risk when taking the study intervention; have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or a history of gastric bypass surgery; have a history or presence of chronic or idiopathic acute pancreatitis.

How the Study Was Run

Design: non-randomized, sequential and open-label.

Everyone knew when Retatrutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-09-12 with completion listed for 2024-07-11.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol (time frame: Predose on Day 1 up to 144 days postdose). PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol (time frame: Predose on Day 1 up to 144 days postdose). PK: Area Under the Concentration Versus Time Curve from Time zero to 24 Hours Postdose (AUC0-24) of Drospirenone (time frame: Predose on Day 1 up to 144 days postdose).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Retatrutide in 46 people.

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

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