Generalized LipodystrophyPhase 2NCT04159415

Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

A Phase 2 study testing Low-Dose REGN4461 and High-dose REGN4461 in people with Generalized Lipodystrophy, run by Regeneron Pharmaceuticals at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Generalized Lipodystrophy
What is being tested?: Low-Dose REGN4461 and High-dose REGN4461
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 8 sitesin 4 countries
Study dates: 7 Jan 2020to 24 Sep 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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
Presence of one or both of the following metabolic abnormalities at screening:
HbA1c ≥ 7% OR
Fasting TG ≥250 mg/dL
Generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit

Who cannot join

Treatment with metreleptin within 1 month of the screening visit
Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
Treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day during the study period
History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit
Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening
Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit.
Pregnant or breast-feeding 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 States3 sites

Regeneron Research Site
Ann Arbor, Michigan, 48105
Regeneron Research Site
Bethesda, Maryland, 20892
Regeneron Research Site
Dallas, Texas, 75390

Other trials in United States

Turkey (Türkiye)3 sites

Regeneron Research Site
Ankara, 06230
Regeneron Research Site
Diyarbakır, 21808
Regeneron Research Site
Izmir, 35100

Other trials in Turkey (Türkiye)

Peru1 site

Regeneron Research Site
Piura, 2665

Other trials in Peru

Russia1 site

Regeneron Research Site
Moscow, 117036

Other trials in Russia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy

The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.

Conditions: Generalized Lipodystrophy
Being tested: Placebo, Low-Dose REGN4461, High-dose REGN4461
Medical subject headings: Lipodystrophy, Congenital Generalized

What participants receive

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

PlaceboDrug
Intravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW).
Low-Dose REGN4461Drug
Also called mibavademab
IV infusion loading dose or SC injection QW.
High-dose REGN4461Drug
Also called mibavademab
IV infusion loading dose or SC injection QW.

Study groups in NCT04159415
Study group	Role	What they receive
Treatment A	Experimental	Not described Receives: Drug: Placebo; Drug: Low-Dose REGN4461; Drug: High-dose REGN4461
Treatment B	Experimental	Not described Receives: Drug: Placebo; Drug: Low-Dose REGN4461; Drug: High-dose REGN4461

What is being measured

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

Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Measured: Baseline, Week 8
Absolute Change From Baseline in Fasting Glucose at Week 8
Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported
Measured: Baseline, Week 8
Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8
Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported
Measured: Baseline, Week 8
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported
Measured: Baseline, Week 8

Secondary outcomes (18)

Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8
The composite score is calculated for each individual participant using baseline and Week 8 measurements of HbA1c and fasting TG.
For each participant, a Z-score is calculated separately for HbA1c and fasting TG, rescaling the change from baseline based on the standard deviation of the baseline value for all participants, as a way of standardizing the change value.
The composite score uses one or both of the calculated Z-scores depending on which parameters were abnormal at baseline. If both, then the participant's composite is the average of the two parameter Z-scores.
At the participant level, a Z-score of zero for either parameter indicates no change in that metabolic parameter, but a composite Z-score of zero can also reflect offsetting changes in metabolic parameters. A negative Z-score would be interpreted as an overall improvement in metabolic function, but a negative Z-score can also result from a decrease in one parameter not being canceled by an increase in the other.
Measured: Baseline, Week 8
Absolute Change From Baseline in Fasting Glucose
Measured: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
Measured: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Percent Change From Baseline in Fasting TG
Measured: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
Measured: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Absolute Change From Baseline in HbA1c
Measured: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
Measured: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52
Absolute Change From Baseline in Weighted Mean Glucose (WMG)
Measured: Baseline, Weeks 16 and 24
Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7%
Measured: Baseline, Weeks 16 and 24
Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT)
Measured: Baseline, Weeks 8, 16, 24
Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7%
Measured: Baseline, Weeks 8, 16, 24
Change From Baseline in Glucose Infusion Rate Per Kilogram (kg) Body Mass During Hyperinsulinemia-euglycemic Clamp
Measured: Baseline, Weeks 8 and 52
Change From Baseline in Glucose Infusion Rate Per kg Body Mass During Hyperinsulinemia-euglycemic Clamp for Participants With Baseline HbA1c ≥7%
Measured: Baseline, Weeks 8 and 52
Change From Baseline in Glucose Clearance Rate (kITT) During Insulin-tolerance Test (ITT)
Measured: Baseline, Weeks 8 and 52
Change From Baseline in Glucose kITT During ITT for Participants With Baseline HbA1c ≥7%
Measured: Baseline, Weeks 8 and 52
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Measured: From first dose of DBTP study treatment through last dose of OLTP 5 study treatment plus 16 weeks (approximately 120 weeks)
Concentrations of Total REGN4461 in Serum Over Time
Measured: Weeks 0 (post-dose), 8, 16 (post-dose), 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Number of Participants With Anti-drug Antibodies (ADA) to REGN4461
Measured: Approximately Week 128

Timeline

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

7 Jan 202024 Sep 2024

First posted12 Nov 2019
Study start7 Jan 2020
Primary completion5 Jan 2022
Study completion24 Sep 2024

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 Generalized 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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04159415
Sponsor's protocol ID: R4461-GLD-1875
Other IDs: 2019-000614-11, 2019
Status last verified: May 2026
First submitted: 7 Nov 2019
Last updated: 15 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
RecruitingPhase 3
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
MEASuRE: Metreleptin Effectiveness And Safety Registry
Generalised Lipodystrophy, Partial Lipodystrophy
Active, not recruiting
Cyclophosphamide in the Treatment of Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes
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All Generalized Lipodystrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
ClinicalTrials.gov ID: NCT04159415
Acronym / sponsor ID: R4461-GLD-1875
Conditions: Generalized Lipodystrophy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 7 Jan 2020 (actual)
Primary completion: 5 Jan 2022 (actual)
Study completion: 24 Sep 2024 (actual)
First posted: 12 Nov 2019 (actual)
Results: Posted 25 Feb 2025

Clinical summary

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

Study design

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

Arm	Type	Receives
Treatment A	Experimental	Drug: Placebo, Drug: Low-Dose REGN4461, Drug: High-dose REGN4461
Treatment B	Experimental	Drug: Placebo, Drug: Low-Dose REGN4461, Drug: High-dose REGN4461

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
Presence of one or both of the following metabolic abnormalities at screening:
Generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit

Key exclusion criteria (8 listed)

Treatment with metreleptin within 1 month of the screening visit
Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
Treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day during the study period
History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit
Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening

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
PlaceboIntravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW).	Drug	Treatment A, Treatment B
Low-Dose REGN4461Also: mibavademabIV infusion loading dose or SC injection QW.	Drug	Treatment A, Treatment B
High-dose REGN4461Also: mibavademabIV infusion loading dose or SC injection QW.	Drug	Treatment A, Treatment B

Primary outcome

Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8
Time frame: Baseline, Week 8
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Absolute Change From Baseline in Fasting Glucose at Week 8
Time frame: Baseline, Week 8
Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported
Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8
Time frame: Baseline, Week 8
Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8
Time frame: Baseline, Week 8
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported

18 secondary outcomes

Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8
Time frame: Baseline, Week 8
Absolute Change From Baseline in Fasting Glucose
Time frame: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7%
Time frame: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Percent Change From Baseline in Fasting TG
Time frame: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL
Time frame: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Absolute Change From Baseline in HbA1c
Time frame: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52
Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7%
Time frame: Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52
Absolute Change From Baseline in Weighted Mean Glucose (WMG)
Time frame: Baseline, Weeks 16 and 24
Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7%
Time frame: Baseline, Weeks 16 and 24
Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT)
Time frame: Baseline, Weeks 8, 16, 24
Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7%
Time frame: Baseline, Weeks 8, 16, 24
Change From Baseline in Glucose Infusion Rate Per Kilogram (kg) Body Mass During Hyperinsulinemia-euglycemic Clamp
Time frame: Baseline, Weeks 8 and 52
Change From Baseline in Glucose Infusion Rate Per kg Body Mass During Hyperinsulinemia-euglycemic Clamp for Participants With Baseline HbA1c ≥7%
Time frame: Baseline, Weeks 8 and 52
Change From Baseline in Glucose Clearance Rate (kITT) During Insulin-tolerance Test (ITT)
Time frame: Baseline, Weeks 8 and 52
Change From Baseline in Glucose kITT During ITT for Participants With Baseline HbA1c ≥7%
Time frame: Baseline, Weeks 8 and 52
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose of DBTP study treatment through last dose of OLTP 5 study treatment plus 16 weeks (approximately 120 weeks)
Concentrations of Total REGN4461 in Serum Over Time
Time frame: Weeks 0 (post-dose), 8, 16 (post-dose), 36, 52; OLTP 5 Weeks 4, 12, 24, 52
Number of Participants With Anti-drug Antibodies (ADA) to REGN4461
Time frame: Approximately Week 128

Results and safety

Results posted to the registry on 25 Feb 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
Treatment Sequence A, DBTP 1: Placebo SC QW	8	8
Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW	8	8
Treatment Sequence A, DBTP 2: Low-dose REGN4461 SC QW	0	0
Treatment Sequence B, DBTP 2: Medium-dose REGN4461 SC QW	0	0
Treatment Sequence A, DBTP 3: Medium-dose REGN4461 SC QW	0	0
Treatment Sequence B, DBTP 3: Medium-dose REGN4461 SC QW	0	0
Treatment Sequence A, OLTP 4: Medium-dose REGN4461 SC QW	0	0
Treatment Sequence B, OLTP 4: Medium-dose REGN4461 SC QW	0	0
Treatment Sequence A, OLTP 5: High-dose	0	0
Treatment Sequence B, OLTP 5: High-dose	0	0

Primary outcome: Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8

Time frame: Baseline, Week 8. Least squares mean (Standard Error). Unit: millimoles per mole (mmol/mol)

Measure	Treatment Sequence A, DBTP 1: Placebo SC QW n = 8	Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW n = 7
Value	-0.1 (0.6)	0.2 (0.7)

Treatment Sequence A, DBTP 1: Placebo SC QW vs Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW: Least Squares (LS) Mean Difference: 0.2 (95% CI -1.9 to 2.3)

Population analysed: Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c \[HbA1c ≥7%\])

Primary outcome: Absolute Change From Baseline in Fasting Glucose at Week 8

Time frame: Baseline, Week 8. Least squares mean (Standard Error). Unit: milligrams per deciliter (mg/dL)

Measure	Treatment Sequence A, DBTP 1: Placebo SC QW n = 8	Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW n = 7
Value	15.5 (18.6)	53.6 (19.9)

Treatment Sequence A, DBTP 1: Placebo SC QW vs Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW: LS Mean Difference: 38.1 (95% CI -21.3 to 97.5)

Population analysed: Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c \[HbA1c ≥7%\])

Primary outcome: Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8

Time frame: Baseline, Week 8. Mean (Standard Error). Unit: mg/dL

Measure	Treatment Sequence A, DBTP 1: Placebo SC QW n = 8	Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW n = 7
Value	-3.7 (19.9)	-3.7 (23.4)

Treatment Sequence A, DBTP 1: Placebo SC QW vs Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW: Adjusted Mean Difference: 0.0 (95% CI -56.9 to 56.9)

Population analysed: Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c \[HbA1c ≥7%\])

Primary outcome: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8

Time frame: Baseline, Week 8. Mean (Standard Error). Unit: percentage of change

Measure	Treatment Sequence A, DBTP 1: Placebo SC QW n = 6	Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW n = 6
Value	-6.0 (29.8)	11.8 (29.8)

Treatment Sequence A, DBTP 1: Placebo SC QW vs Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW: Adjusted Mean Difference: 17.8 (95% CI -67.6 to 103.2)

Population analysed: Triglyceride analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline fasting TG (TG ≥250 mg/dL)

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug through end of study (approximately 128 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Sequence A: DBTP 1	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8
Treatment Sequence B: DBTP 1	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Treatment Sequence A: DBTP 2	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Treatment Sequence B: DBTP 2	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Treatment Sequence A: DBTP 3	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8
Treatment Sequence B: DBTP 3	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8
Treatment Sequence A: OLTP 4	1 of 8 (12.5%)	8 of 8 (100%)	0 of 8
Treatment Sequence B: OLTP 4	3 of 8 (37.5%)	7 of 8 (87.5%)	0 of 8
Treatment Sequence A: OLTP 5	1 of 6 (16.7%)	5 of 6 (83.3%)	0 of 6
Treatment Sequence B: OLTP 5	1 of 4 (25%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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 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 Low-Dose REGN4461 and High-dose REGN4461 in people with Generalized Lipodystrophy, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jun 2026. 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, Turkey (Türkiye), Peru, Russia. 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 25 Feb 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?

Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8 (time frame: Baseline, Week 8). The study lists 4 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 NCT04159415.

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 15 Jun 2026.