Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

What Was Tested

This registered phase 2 trial tested Dulaglutide for sexual function & libido (women and men).

This placebo-controlled, double-blind crossover study is to evaluate the GLP-1 analogue dulaglutide regarding changes in sexuality, the mood and the reproductive axis in healthy men.

It had two arms (groups): Phase a (V1a-Ev2a): Dulaglutide first- Phase b (V1b-Ev2b) Placebo second (experimental) and Phase a (V1a-Ev2a): Placebo first- Phase b (V1b-Ev2b) Dulaglutide second (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Healthy men with normal weight (BMI 18.5-25kg/m2 or BMI 25.1-30kg/m2 and waist circumference \<102cm). Written informed consent. Active sex life (sex with partner or masturbation ≥2x/week). Satisfactory sex life.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: history of pancreatitis; history of psychiatric disease (by questioning the participant, also regarding current psychiatric treatment); daily nicotine abuse.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

In the crossover set-up each of the sexual function & libido (women and men) participants took both Dulaglutide and the comparison in turn, acting as their own control.

Blinding on both sides kept the sexual function & libido (women and men) participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2021-05-05 with completion listed for 2022-09-05.

It ran at 1 site in Switzerland.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 4 secondary outcomes, for example Mood changes, assessed by the German Version of the Patient Health Questionnaire-9 for Depression (PHQ-9), Change in hormones of the reproductive axis, Change in semen concentration and Change in semen motility.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 26 people with sexual function & libido (women and men).

Its size is small, so on its own it can only give an early look.

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

More context: the Dulaglutide compound page, Sexual function & libido (women and men) research.