Monogenic ObesityPhase 3NCT07220772
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
A Phase 3 study testing Mibavademab in people with Monogenic Obesity, run by Regeneron Pharmaceuticals at 3 sites in 2 countries.
Trial summary
This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity. Monogenic obesity is caused by a change in the leptin gene that keeps it from working properly. This causes the body to not be able to feel full or control feelings of hunger. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Monogenic Obesity
- What is being tested?
- Mibavademab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Feb 2026to 21 Apr 2028
- Phase
- Phase 3
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit
- Has class ≥2 obesity at screening and at baseline, as defined in the protocol
Who cannot join
- Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening
- History of bariatric surgery within approximately the past 12 months of study screening
- History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening
- History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene
- History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug
- Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation
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- Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening
- Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Education and Research Hospital
Ankara, 06230
Sevde Nur Firat, +90 555 560 04 42, sevdenursuruc@yahoo.com
- Recruiting
Erciyes University
Kayseri, 38280
Nihal Hatipoglu, +90 505 578 05 37, nihalhatipoglu@yahoo.com
Germany1 site, 1 recruiting
- Recruiting
ULM University Medical Centre
Ulm, 89075
Julia Schnurbein, 7315005740, julia.schnurbein@uniklinik-ulm.de
About this study
Official title: An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene
This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity. Monogenic obesity is caused by a change in the leptin gene that keeps it from working properly. This causes the body to not be able to feel full or control feelings of hunger.
The aim of the study is to see how well mibavademab controls the body weight and how safe it is.
Read more
The study is looking at several other research questions, including:
- How much mibavademab is in the blood at different times
- Whether the body makes proteins called antibodies against mibavademab (which could stop mibavademab from working as well or could lead to side effects)
- What side effects may happen from taking mibavademab
- Conditions
- Monogenic Obesity
- Being tested
- Mibavademab
- Keywords
- Biallelic loss of function variants of the LEP gene mutations, Leptin deficiency
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MibavademabDrug
Also called REGN4461
Administered as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Mibavademab | Experimental | Not described Receives: Drug: Mibavademab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Body Mass Index (BMI)
Measured: Baseline to Week 24
Secondary outcomes (17)
Percent change in BMI
Measured: Baseline to Week 52
Absolute change in BMI
Measured: Baseline, Through Week 52
Percent change in body weight
Measured: Baseline, Through Week 52
Absolute change in body weight
Measured: Baseline, Through Week 52
Change in waist circumference
Participants aged ≥18 years
Measured: Baseline, Through Week 52
Change in absolute total fat mass by whole body DXA
Measured: Baseline, Through Week 52
Change in percent total fat mass by whole body DXA
Measured: Baseline, Through Week 52
Change in absolute regional fat mass by whole body DXA
Measured: Baseline, Through Week 52
Change in percent regional fat mass by whole body DXA
Measured: Baseline, Through Week 52
Change in scores in the symptoms of hyperphagia questionnaire
Symptoms of Hyperphagia - Caregiver Version© is completed by a caregiver. Symptoms of Hyperphagia - Patient Version© is completed by the participants who are aged <12 years or for participants who are unable to self-complete. The questionnaires both assesses the frequency of hunger symptoms on a categorical scale (Never, 1 or 2 times, 3 or more times) over the past 24 hours and are scored combining the total scores across the items. Higher scores indicate greater severity.
Measured: Baseline, Through Week 52
Change in scores in the impacts of hyperphagia questionnaire
For participants who are aged <12 years or for participants who are unable to self-complete, the Impacts of Hyperphagia - Caregiver Version© is completed by a caregiver. For participants aged ≥12 years who are able to self-report, the Impacts of Hyperphagia - Patient Version© is completed by the participant. Both questionnaires assess the impact of hyperphagia on a categorical scale (range: not at all, a little, moderately, a great deal). The participant version is scored using a total score across the 5 items. The caregiver version is scored separately for each section. Higher scores indicate a greater impact of hyperphagia.
Measured: Baseline, Through Week 52
Change in scores in the hunger questionnaire
The Daily Hunger Assessment is a daily, single item measuring hunger for participants aged ≥12 years who are able to self-complete, participants are asked to rate their highest level of hunger over for the day, where "0" is "not hungry at all" to "10" the hungriest possible."
Measured: Baseline, Through Week 52
Number of treatment-emergent adverse events (TEAEs)
Measured: Through Week 65
Severity of TEAEs
Measured: Through Week 65
Concentrations of total mibavademab in serum
Measured: Through Week 65
Incidence of anti-drug antibody (ADA) to mibavademab
Measured: Through Week 65
Titer of ADA to mibavademab
Measured: Through Week 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start9 Feb 2026
- Primary completion18 Jun 2027 (estimated)
- Study completion21 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monogenic ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220772
- Sponsor's protocol ID
- R4461-MOB-2471
- Other IDs
- 2024-518674-14-00
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
- Expanded access
- Available