TerminatedPhase 2/3

Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome

Stopped: Livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors

United States158 participantsStarted 2019-03-25

Plain-language summary

This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).

Who can participate

Age range4 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed genetic diagnosis of PWS * Evidence of increased appetite or hyperphagia * Patient must have a single primary caregiver who should be available for certain durations of the study * BMI ≤ 65 kg/m2 * Growth hormone treatment permitted if doses have been stable for at least 1 month prior to screening Exclusion Criteria: * History of chronic liver disease * Type 1 diabetes mellitus * HbA1c \> 10% * Body weight \<20 kg

What they're measuring

Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT)

Timeframe: Baseline to month 3

Trial details

NCT IDNCT03790865

SponsorMillendo Therapeutics SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-26

Results submitted2021-01-21

View on ClinicalTrials.gov More Prader-Willi Syndrome trials