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New drug hopes to curb rare genetic obesity

NCT ID NCT07220772

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called mibavademab in people with a rare form of obesity caused by a faulty leptin gene. The drug aims to help control hunger and body weight. Only 4 participants will be enrolled to see how well it works and if it is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mibavademab (a leptin receptor agonist)
What this could lead to
If it works, this could provide a treatment option for people with a rare form of obesity caused by a faulty leptin gene.
What could go wrong
This is a very small early-phase trial with only 4 participants, so results may not apply to everyone. The drug may cause side effects or not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit 2. Has class ≥2 obesity at screening and at baseline, as defined in the protocol Key Exclusion Criteria: 1. Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening 2. History of bariatric surgery within approximately the past 12 months of study screening 3. History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening 4. History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene 5. 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 6. 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 7. Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening 8. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ULM University Medical Centre

    RECRUITING

    Ulm, 89075, Germany

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