Trial · NCT03790865
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
NCT03790865, Phase 2, Phase 3, Terminated, Millendo Therapeutics SAS; results first posted 2021-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome. Trials, record NCT03790865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03790865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
- NCT number
- NCT03790865
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 158 participants, actual
- Lead sponsor
- Millendo Therapeutics SAS
- Conditions
- Prader-Willi Syndrome, Hyperphagia
- Interventions
- Livoletide, Placebo
- First posted
- 2019-01-02
- Last updated
- 2021-02-17
- Results first posted
- 2021-02-17
- Limitations and caveats
The double-blind, placebo-controlled phase 2b study did not meet the primary endpoint or any of the secondary endpoints. Therefore, the Sponsor has decided to discontinue further development of livoletide.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT) | Baseline to month 3 | Change from baseline to the end of the 3-month Core Period for HQ-CT total score. The HQ-CT score range is 0 to 36 where the higher score represents more severe abnormal food related behaviors. |
| Secondary | Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Baseline to month 3 | Total body fat mass was assessed using dual energy X-ray absorptiometry (DXA) scan. DXAs were conducted at each local facility using standardized procedures and settings. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex |
| Secondary | Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Baseline to month 3 | The waist circumference was measured in fasting condition at the superior border of iliac crest, according to recommendations from the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey, Revised 2007. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex |
| Secondary | Percentage Change From Baseline to Month 3 in Body Weight in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Baseline to month 3 | Patients were weighed in fasting condition, clothed (underwear, light gown or light clothing), without footwear or heavy jewelry, using a calibrated scale. The same scale should be used throughout the study if possible. The conditions under which patients are weighed should be kept consistent if possible. Overweight/obese patients were defined as follows: * patients ≥18 years of age: BMI ≥27 kg/m2 * patients 4-17 years of age: BMI ≥90th percentile for the same age and sex |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT) | Baseline to month 3 | The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS. | score on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Baseline to month 3 | The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS.~For this endpoint, only patients considered overweight/obese at baseline were included in the analysis.~Overweight/obese patients were defined as follows:~* patients ≥18 years of age: BMI ≥27 kg/m2~* patients 4-17 years of age: BMI ≥90th percentile for the same age and sex | percent change | MEAN |
| SECONDARY | Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Baseline to month 3 | The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS.~For this endpoint, only patients considered overweight/obese at baseline were included in the analysis.~Overweight/obese patients were defined as follows:~* patients ≥18 years of age: BMI ≥27 kg/m2~* patients 4-17 years of age: BMI ≥90th percentile for the same age and sex | cm | MEAN |
| SECONDARY | Percentage Change From Baseline to Month 3 in Body Weight in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Baseline to month 3 | The Full Analysis Set (FAS) included all randomized patients. Efficacy analyses for the Phase 2b Core Period were performed on the FAS.~For this endpoint, only patients considered overweight/obese at baseline were included in the analysis.~Overweight/obese patients were defined as follows:~* patients ≥18 years of age: BMI ≥27 kg/m2~* patients 4-17 years of age: BMI ≥90th percentile for the same age and sex | percent change | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT) | Low-Dose Livoletide | -5.1 | Standard Error 7.76 | score on a scale | |
| Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT) | High-Dose Livoletide | -3.6 | Standard Error 6.08 | score on a scale | |
| Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT) | Placebo | -3.3 | Standard Error 5.77 | score on a scale | |
| Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Low-Dose Livoletide | 0.33 | Standard Deviation 3.806 | percent change | |
| Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese | High-Dose Livoletide | 3.48 | Standard Deviation 4.429 | percent change | |
| Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Placebo | -0.36 | Standard Deviation 4.302 | percent change | |
| Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Low-Dose Livoletide | 0.92 | Standard Deviation 5.703 | cm | |
| Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese | High-Dose Livoletide | 0.11 | Standard Deviation 4.969 | cm | |
| Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Placebo | -0.45 | Standard Deviation 3.674 | cm | |
| Percentage Change From Baseline to Month 3 in Body Weight in Patients Eight to 65 Years of Age Defined as Overweight/Obese | Low-Dose Livoletide | 1.39 | Standard Deviation 3.313 | percent change |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-Dose Livoletide | 52 | |
| Overall Study | STARTED | High-Dose Livoletide | 52 | |
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | COMPLETED | Low-Dose Livoletide | 52 | |
| Overall Study | COMPLETED | High-Dose Livoletide | 50 | |
| Overall Study | COMPLETED | Placebo | 54 | |
| Overall Study | NOT COMPLETED | Low-Dose Livoletide | 0 | |
| Overall Study | NOT COMPLETED | High-Dose Livoletide | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events87
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Low-Dose Livoletide | 8 | 52 | 10 |
| other | Diarrhea | Gastrointestinal disorders | High-Dose Livoletide | 4 | 52 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 5 | 54 | 5 |
| other | Abdominal Pain | Gastrointestinal disorders | Low-Dose Livoletide | 1 | 52 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | High-Dose Livoletide | 0 | 52 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 2 | 54 | 3 |
| other | Constipation | Gastrointestinal disorders | Low-Dose Livoletide | 2 | 52 | 2 |
| other | Constipation | Gastrointestinal disorders | High-Dose Livoletide | 0 | 52 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 54 | 1 |
| other | Nausea | Gastrointestinal disorders | Low-Dose Livoletide | 1 | 52 | 1 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-Dose Livoletide | 0 | 52 |
| Total, all-cause mortality | High-Dose Livoletide | 0 | 52 |
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, other adverse events | Low-Dose Livoletide | 34 | 52 |
| Total, other adverse events | High-Dose Livoletide | 34 | 52 |
| Total, other adverse events | Placebo | 34 | 54 |
| Total, serious adverse events | Low-Dose Livoletide | 2 | 52 |
| Total, serious adverse events | High-Dose Livoletide | 1 | 52 |
| Total, serious adverse events | Placebo | 1 | 54 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03790865
GET https://conductscience.org/api/trials/v1/NCT03790865/events?page=2