A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2022-01-26

Brief Summary

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The purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments.

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Detailed Description

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This study will include 2 treatment periods and will utilize a crossover study design with a 7- to 14-day washout period between each 22-day treatment period.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lu AG06466

Participants will receive an oral titrated dose of Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Group Type EXPERIMENTAL

Lu AG06466

Intervention Type DRUG

Lu AG06466 - capsules

Placebo

Participants will receive an oral dose of placebo matching to Lu AG06466 once daily for 22 days in 1 of 2 treatment periods.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo - capsules

Interventions

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Lu AG06466

Lu AG06466 - capsules

Intervention Type DRUG

Placebo

Placebo - capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The participant has a body mass index (BMI) of ≥18.5 and ≤38.0 kilograms (kg)/square meter (m\^2).
* The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score \>4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit.
* The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria

* The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No