Trials / Terminated
TerminatedNCT03790865
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Millendo Therapeutics SAS · Industry
- Sex
- All
- Age
- 4 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The protocol includes 2 consecutive parts: 1. The first part is a Phase 2b dose-response study consisting of a 3-month double-blind, placebo-controlled Core Period followed by a 9-month Extension Period. 2. The second part is a Phase 3 study consisting of a 6-month double-blind, placebo-controlled Core Period followed by a 6-month Extension Period. Phase 3 may be initiated following review of safety and efficacy results at the completion of the Phase 2b Core Period. A total of approximately 50 patients per group (8 to 65 years of age) will be randomized (approximately 150 patients in total). In addition to this cohort of 150 patients, a separate cohort of patients 4 to 7 years of age will also be randomized. Note: The 8-65 year old cohort has been fully enrolled. Enrollment into the 4-7 year age cohort remains ongoing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Livoletide | Daily subcutaneous injection |
| DRUG | Placebo | Daily subcutaneous injection |
Timeline
- Start date
- 2019-03-25
- Primary completion
- 2020-02-26
- Completion
- 2020-05-25
- First posted
- 2019-01-02
- Last updated
- 2021-02-17
- Results posted
- 2021-02-17
Locations
37 sites across 8 countries: United States, Australia, Belgium, France, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03790865. Inclusion in this directory is not an endorsement.