Trial · NCT05088460
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
NCT05088460, Phase 2, Terminated, Regeneron Pharmaceuticals; results first posted 2025-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD). Trials, record NCT05088460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05088460
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
- NCT number
- NCT05088460
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Familial Partial Lipodystrophy, Metabolic Abnormalities
- Interventions
- REGN4461, Matching Placebo
- First posted
- 2021-10-22
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2021-000138-33
- Results first posted
- 2025-07-02
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) | Baseline to week 12 | Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (\> 200 mg/dL) and with baseline leptin \< 8.0 ng/mL (Cohort A). |
| Primary | Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A) | Baseline to week 12 | Change in HbA1c was reported for participants with elevated baseline HbA1c (\> 7.0%) and with baseline leptin \< 8.0 ng/mL (Cohort A). |
| Secondary | Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Baseline to week 12 | Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (\>200 mg/dL) in Cohort B and Cohorts A + B. |
| Secondary | Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B) | Baseline to week 12 | Change in HbA1c was reported for participants with elevated baseline HbA1c (\>7.0%) in Cohort B and Cohorts A + B. |
| Secondary | Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1) | Baseline, Week 12, Week 24 | Percent change in fasting serum TG was reported for participants in Study Arm 1. |
| Secondary | Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2) | Baseline, Week 12, Week 24 | Percent change in fasting serum TG was reported for participants in Study Arm 2. |
| Secondary | Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1) | Baseline, Week 12, Week 24 | Change from baseline in HbA1c was reported for participants in Study Arm 1. |
| Secondary | Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2) | Baseline, Week 12, Week 24 | Change from baseline in HbA1c was reported for participants in Study Arm 2. |
| Secondary | Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1) | Baseline, Week 12, Week 24 | Change from baseline in fasting glucose was reported for participants in Study Arm 1. |
| Secondary | Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2) | Baseline, Week 12, Week 24 | Change from baseline in fasting glucose was reported for participants in Study Arm 2. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) | Baseline to week 12 | The Full Analysis Set (FAS) included all randomized participants who received any study drug in the double-blind treatment period (DBTP) and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | percent change | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A) | Baseline to week 12 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | percentage of glycated hemoglobin | MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Baseline to week 12 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B) | Baseline to week 12 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | percentage of glycated hemoglobin | MEAN |
| SECONDARY | Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1) | Baseline, Week 12, Week 24 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2) | Baseline, Week 12, Week 24 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point. | percent change | MEAN |
| SECONDARY | Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1) | Baseline, Week 12, Week 24 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point. | percentage of glycated hemoglobin | MEAN |
| SECONDARY | Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2) | Baseline, Week 12, Week 24 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point. | percentage of glycated hemoglobin | MEAN |
| SECONDARY | Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1) | Baseline, Week 12, Week 24 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point. | milligrams per deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2) | Baseline, Week 12, Week 24 | The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point. | mg/dL | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) | Arm 1 Cohort A: Placebo to REGN4461 | -11.30 | Standard Deviation 46.306 | percent change | |
| Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) | Arm 2 Cohort A: REGN4461 to REGN4461 | -38.97 | Standard Deviation 16.998 | percent change | |
| Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A) | Arm 1 Cohort A: Placebo to REGN4461 | -0.05 | Standard Deviation 0.451 | percentage of glycated hemoglobin | |
| Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A) | Arm 2 Cohort A: REGN4461 to REGN4461 | -1.08 | Standard Deviation 1.108 | percentage of glycated hemoglobin | |
| Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Arm 1 Cohort B: Placebo to REGN4461 | 36.78 | Standard Deviation 44.863 | percent change | |
| Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Arm 2 Cohort B: REGN4461 to REGN4461 | -35.59 | Standard Deviation 8.754 | percent change | |
| Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Arm 1 Combined Cohort A + B: Placebo to REGN4461 | 10.07 | Standard Deviation 49.689 | percent change | |
| Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 | -37.62 | Standard Deviation 13.752 | percent change | |
| Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B) | Arm 1 Cohort B: Placebo to REGN4461 | -0.20 | Standard Deviation 0.283 | percentage of glycated hemoglobin | |
| Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B) | Arm 2 Cohort B: REGN4461 to REGN4461 | -0.90 | Standard Deviation 0.964 | percentage of glycated hemoglobin |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 Cohort A: Placebo to REGN4461 | 6 | |
| Overall Study | STARTED | Arm 2 Cohort A: REGN4461 to REGN4461 | 6 | |
| Overall Study | STARTED | Arm 1 Cohort B: Placebo to REGN4461 | 4 | |
| Overall Study | STARTED | Arm 2 Cohort B: REGN4461 to REGN4461 | 4 | |
| Overall Study | Completed Treatment During DBTP | Arm 1 Cohort A: Placebo to REGN4461 | 5 | |
| Overall Study | Completed Treatment During DBTP | Arm 2 Cohort A: REGN4461 to REGN4461 | 6 | |
| Overall Study | Completed Treatment During DBTP | Arm 1 Cohort B: Placebo to REGN4461 | 4 | |
| Overall Study | Completed Treatment During DBTP | Arm 2 Cohort B: REGN4461 to REGN4461 | 4 | |
| Overall Study | Completed Treatment During SBTP | Arm 1 Cohort A: Placebo to REGN4461 | 5 | |
| Overall Study | Completed Treatment During SBTP | Arm 2 Cohort A: REGN4461 to REGN4461 | 5 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events984
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 | Influenza | Infections and infestations | DBTP Arm 1 Cohort A: Placebo | 2 | 6 | 2 |
| other | Influenza | Infections and infestations | DBTP Arm 2 Cohort A: REGN4461 | 2 | 6 | 2 |
| other | Influenza | Infections and infestations | DBTP Arm 1 Cohort B: Placebo | 1 | 4 | 1 |
| other | Influenza | Infections and infestations | DBTP Arm 2 Cohort B: REGN4461 | 0 | 4 | 0 |
| other | Influenza | Infections and infestations | SBTP Arm 1 Cohort A: Placebo to REGN4461 | 0 | 5 | 0 |
| other | Influenza | Infections and infestations | SBTP Arm 2 Cohort A: REGN4461 to REGN4461 | 0 | 6 | 0 |
| other | Influenza | Infections and infestations | SBTP Arm 1 Cohort B: Placebo to REGN4461 | 0 | 3 | 0 |
| other | Influenza | Infections and infestations | SBTP Arm 2 Cohort B: REGN4461 to REGN4461 | 0 | 4 | 0 |
| other | Bacterial infection | Infections and infestations | DBTP Arm 1 Cohort A: Placebo | 1 | 6 | 1 |
| other | Bacterial infection | Infections and infestations | DBTP Arm 2 Cohort A: REGN4461 | 0 | 6 | 0 |
1 to 10 of 984Source ClinicalTrials.gov
See all 984 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DBTP Arm 1 Cohort A: Placebo | 0 | 6 |
| Total, all-cause mortality | DBTP Arm 2 Cohort A: REGN4461 | 0 | 6 |
| Total, all-cause mortality | DBTP Arm 1 Cohort B: Placebo | 0 | 4 |
| Total, all-cause mortality | DBTP Arm 2 Cohort B: REGN4461 | 0 | 4 |
| Total, all-cause mortality | SBTP Arm 1 Cohort A: Placebo to REGN4461 | 0 | 5 |
| Total, all-cause mortality | SBTP Arm 2 Cohort A: REGN4461 to REGN4461 | 0 | 6 |
| Total, all-cause mortality | SBTP Arm 1 Cohort B: Placebo to REGN4461 | 0 | 3 |
| Total, all-cause mortality | SBTP Arm 2 Cohort B: REGN4461 to REGN4461 | 0 | 4 |
| Total, other adverse events | DBTP Arm 1 Cohort A: Placebo | 6 | 6 |
| Total, other adverse events | DBTP Arm 2 Cohort A: REGN4461 | 6 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 2 Combined Cohort A + B: REGN4461 to REGN4461 vs Arm 1 Combined Cohort A + B: Placebo to REGN4461: Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response |
Source Trial comparisons
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.
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GET https://conductscience.org/api/trials/v1/NCT05088460/results?page=2