CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 88 enrolled
Drug / intervention
Liraglutide Pen Injector [Saxenda] +1 moredrug
Likely dose
Liraglutide Pen Injector [Saxenda] 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03480022
NCT03480022Phase 3Completed

A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)

Woman's·interventional·Posted Mar 27, 2018·Updated Jun 7, 2021

In Brief

A Phase 3 clinical trial evaluating Liraglutide Pen Injector [Saxenda] and Placebo Liraglutide Pen Injector for Pre Diabetes and 2 related conditions. Completed, enrolled 88 participants across 1 site.

Detailed Summary

There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported in other studies can be confirmed in a selected population of hyperandrogenic patients, especially with medications currently approved for weight reduction. High dose liraglutide alone results in significant weight reduction in obese women without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic females with PCOS treated with this agent . Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and androgen excess in obese women diagnosed with PCOS are lacking. The investigators aim to elucidate the most efficacious weight reduction regime in obese PCOS women. The investigators further hope to determine which treatment(s) addressing the multifaceted disturbances of this disorder in patients with PCOS and obesity emerges as the preferable therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 27, 2018
Enrollment StartSep 26, 2018
Primary CompletionFeb 22, 2021
Study CompletionMay 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.3 years ago

Interventions

Liraglutide Pen Injector [Saxenda]drug

daily sc injection of liraglutide with final dose of 3mg daily

Placebo Liraglutide Pen Injectordrug

daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo