LipodystrophyNCT04710056
Compassionate Use or Expanded Access of Mibavademab
A study testing REGN4461 in people with Lipodystrophy and Generalized Lipodystrophy (GLD), run by Regeneron Pharmaceuticals.
Trial summary
Provide Expanded Access to REGN4461 for patients with diseases associated with deficient leptin signaling. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lipodystrophy, Generalized Lipodystrophy (GLD), Monogenic Obesity (MOB)
- What is being tested?
- REGN4461
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Key Inclusion: N/A
Key Exclusion: N/A
Trial locations and contacts
No sites are listed yet.
Requests for Expanded Access must be initiated by a treating physician. Physicians should contact contact
About this study
Provide Expanded Access to REGN4461 for patients with diseases associated with deficient leptin signaling.
Read the detailed description
Expanded Access requests are only being considered in response to Individual Patient and Intermediate-Size Population EAP Investigational New Drug (IND) applications. Availability will depend on location.
- Being tested
- REGN4461
- Keywords
- Leptin (LEP), Leptin Receptors (LEPR), Biallelic Loss of Function Variants of the LEP Gene
- Medical subject headings
- Lipodystrophy, Lipodystrophy, Congenital Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN4461Drug
Also called mibavademab
To be provided by Regeneron
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710056
- Sponsor's protocol ID
- R4461 - Mibavademab
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use or Expanded Access of Mibavademab
- ClinicalTrials.gov ID
- NCT04710056
- Acronym / sponsor ID
- R4461 - Mibavademab
- Keywords
- Leptin (LEP), Leptin Receptors (LEPR), Biallelic Loss of Function Variants of the LEP Gene
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provide Expanded Access to REGN4461 for patients with diseases associated with deficient leptin signaling.
Detailed description
Expanded Access requests are only being considered in response to Individual Patient and Intermediate-Size Population EAP Investigational New Drug (IND) applications. Availability will depend on location.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
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: mibavademabTo be provided by Regeneron | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Requests for Expanded Access must be initiated by a treating physician. Physicians should contact contact
Questions about this trial
What is this clinical trial studying?
A study testing REGN4461 in people with Lipodystrophy and Generalized Lipodystrophy (GLD), run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Requests for Expanded Access must be initiated by a treating physician. Physicians should contact (844-734-6643, Managedaccessrequests@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 27 Oct 2026.