Familial Partial LipodystrophyPhase 2LEAPNCT05088460

A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)

A Phase 2 study testing REGN4461 in people with Familial Partial Lipodystrophy and Metabolic Abnormalities, run by Regeneron Pharmaceuticals at 8 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be evaluated for patients in Cohort A only: To evaluate the effect of REGN4461 on fasting… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Familial Partial Lipodystrophy, Metabolic Abnormalities
What is being tested?: REGN4461
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 8 sitesin 4 countries
Study dates: 28 Feb 2022to 18 Apr 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)
No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol

Who cannot join

Treatment with metreleptin within 3 months of the screening visit
Patients with a diagnosis of generalized lipodystrophy
Patients with a diagnosis of acquired lipodystrophy
Pregnant or breastfeeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

8 sites in 4 countries.

Country

City, postcode or hospital

8 sites in 4 countries

United States5 sites

University of Michigan
Ann Arbor, Michigan, 48109
National Institute of Health
Bethesda, Maryland, 20892
Excel Medical Clinical Trials - A Flourish Research Site
Boca Raton, Florida, 33434
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

France1 site

ICAN, Institute of Cardiometabolism and Nutrition
Paris, 75013

Other trials in France

Spain1 site

Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
Santiago de Compostela, Galicia, 15706

Other trials in Spain

Turkey (Türkiye)1 site

Ege University Faculty of Medicine
Izmir, Bornova, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL

The primary objectives will be evaluated for patients in Cohort A only:

To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)

The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:

To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia

The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:

To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
To evaluate the effect of REGN4461 on hunger
To evaluate safety and tolerability of REGN4461
To characterize the concentration profile of REGN4461 over time
To assess immunogenicity to REGN4461

Conditions: Familial Partial Lipodystrophy, Metabolic Abnormalities
Being tested: REGN4461, Matching Placebo
Medical subject headings: Lipodystrophy, Familial Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REGN4461Drug
Also called mibavademab
Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).
Matching PlaceboDrug
Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).

Study groups in NCT05088460
Study group	Role	What they receive
Study Arm 1	Experimental	Randomized to placebo for 12 weeks and then crossover to REGN4461 for 12 weeks Receives: Drug: REGN4461; Drug: Matching Placebo
Study Arm 2	Experimental	Randomized to receive REGN4461 for 24 weeks Receives: Drug: REGN4461

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)
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).
Measured: Baseline to week 12
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)
Change in HbA1c was reported for participants with elevated baseline HbA1c (> 7.0%) and with baseline leptin < 8.0 ng/mL (Cohort A).
Measured: Baseline to week 12

Secondary outcomes (17)

Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)
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.
Measured: Baseline to week 12
Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B)
Change in HbA1c was reported for participants with elevated baseline HbA1c (>7.0%) in Cohort B and Cohorts A + B.
Measured: Baseline to week 12
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1)
Percent change in fasting serum TG was reported for participants in Study Arm 1.
Measured: Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2)
Percent change in fasting serum TG was reported for participants in Study Arm 2.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1)
Change from baseline in HbA1c was reported for participants in Study Arm 1.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2)
Change from baseline in HbA1c was reported for participants in Study Arm 2.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1)
Change from baseline in fasting glucose was reported for participants in Study Arm 1.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2)
Change from baseline in fasting glucose was reported for participants in Study Arm 2.
Measured: Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1)
Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1.
Measured: Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2)
Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry.
Measured: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness.
Measured: Baseline, Week 12, Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Day 169
Concentrations of REGN4461 in Serum
Measured: Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response
Measured: Up to Day 281

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202218 Apr 2024

First posted22 Oct 2021
Study start28 Feb 2022
Primary completion13 Dec 2023
Study completion18 Apr 2024

Why it stopped: Sponsor Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Familial Partial LipodystrophyStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05088460
Sponsor's protocol ID: R4461-PLD-20100
Other IDs: 2021-000138-33
Acronym: LEAP
Status last verified: Aug 2025
First submitted: 12 Oct 2021
Last updated: 16 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Not yet recruitingObservational study
Sexual Quality of Life in Female Patients With Lipodystrophy Syndromes or Turner's Syndrome: a Case-control Study
Lipodystrophy Congenital Generalized, Lipodystrophy, Familial Partial
RecruitingObservational study
Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)
Lipodystrophy
Recruiting
Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome, Familial Partial Lipodystrophy
RecruitingPhase 3
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Familial Partial Lipodystrophy

All Familial Partial Lipodystrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy
ClinicalTrials.gov ID: NCT05088460
Acronym / sponsor ID: LEAP / R4461-PLD-20100
Conditions: Familial Partial Lipodystrophy, Metabolic Abnormalities
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor Decision
Enrolment: 20 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 28 Feb 2022 (actual)
Primary completion: 13 Dec 2023 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 22 Oct 2021 (actual)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL

The primary objectives will be evaluated for patients in Cohort A only:

To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)

The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:

To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia

The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:

To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
To evaluate the effect of REGN4461 on hunger
To evaluate safety and tolerability of REGN4461
To characterize the concentration profile of REGN4461 over time
To assess immunogenicity to REGN4461

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Arm 1	Experimental	Drug: REGN4461, Drug: Matching PlaceboRandomized to placebo for 12 weeks and then crossover to REGN4461 for 12 weeks
Study Arm 2	Experimental	Drug: REGN4461Randomized to receive REGN4461 for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)

Key exclusion criteria (5 listed)

Treatment with metreleptin within 3 months of the screening visit
Patients with a diagnosis of generalized lipodystrophy
Patients with a diagnosis of acquired lipodystrophy
Pregnant or breastfeeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REGN4461Also: mibavademabIntravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).	Drug	Study Arm 1, Study Arm 2
Matching PlaceboIntravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).	Drug	Study Arm 1

Primary outcome

Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)
Time frame: 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).
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)
Time frame: 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).

17 secondary outcomes

Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)
Time frame: Baseline to week 12
Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B)
Time frame: Baseline to week 12
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1)
Time frame: Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2)
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1)
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2)
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1)
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2)
Time frame: Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1)
Time frame: Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2)
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score
Time frame: Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score
Time frame: Baseline, Week 12, Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 169
Concentrations of REGN4461 in Serum
Time frame: Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response
Time frame: Up to Day 281

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 Cohort A: Placebo to REGN4461	6	6
Arm 2 Cohort A: REGN4461 to REGN4461	6	6
Arm 1 Cohort B: Placebo to REGN4461	4	4
Arm 2 Cohort B: REGN4461 to REGN4461	4	4

Primary outcome: Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)

Time frame: Baseline to week 12. Mean (Standard Deviation). Unit: percent change

Measure	Arm 1 Cohort A: Placebo to REGN4461 n = 5	Arm 2 Cohort A: REGN4461 to REGN4461 n = 6
Value	-11.30 (46.306)	-38.97 (16.998)

Population analysed: 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.

Primary outcome: Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)

Time frame: Baseline to week 12. Mean (Standard Deviation). Unit: percentage of glycated hemoglobin

Measure	Arm 1 Cohort A: Placebo to REGN4461 n = 4	Arm 2 Cohort A: REGN4461 to REGN4461 n = 5
Value	-0.05 (0.451)	-1.08 (1.108)

Population analysed: 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.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent up to day 281 (end of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DBTP Arm 1 Cohort A: Placebo	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
DBTP Arm 2 Cohort A: REGN4461	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
DBTP Arm 1 Cohort B: Placebo	1 of 4 (25%)	4 of 4 (100%)	0 of 4
DBTP Arm 2 Cohort B: REGN4461	0 of 4 (0%)	4 of 4 (100%)	0 of 4
SBTP Arm 1 Cohort A: Placebo to REGN4461	1 of 5 (20%)	3 of 5 (60%)	0 of 5
SBTP Arm 2 Cohort A: REGN4461 to REGN4461	1 of 6 (16.7%)	5 of 6 (83.3%)	0 of 6
SBTP Arm 1 Cohort B: Placebo to REGN4461	0 of 3 (0%)	3 of 3 (100%)	0 of 3
SBTP Arm 2 Cohort B: REGN4461 to REGN4461	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Related trials for Familial Partial Lipodystrophy

RecruitingPhase 3
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

8 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REGN4461 in people with Familial Partial Lipodystrophy and Metabolic Abnormalities, run by Regeneron Pharmaceuticals at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, France, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05088460.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.