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New pill targets hard-to-treat obesity after brain injury

NCT ID NCT06046443

Disease control Sponsor: Rhythm Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an experimental daily pill, LB54640, in 28 people aged 12 and older with hypothalamic obesity—a condition where brain injury causes rapid, severe weight gain. For the first 14 weeks, some received the drug and some a placebo to see if it safely reduces weight and hunger. Those who finished could continue on the drug for up to a year.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Jul 2024

Finished

Feb 2026

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

12 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: * Documented evidence of acquired hypothalamic obesity (HO) * Age 12 years and older * Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients \<18 years of age * Male and female participants agree to follow study contraception requirements and use a highly effective form of contraception throughout the study and for 90 days after the study Key Exclusion Criteria: * Weight loss \>2% in the previous 3 months for patients ≥18 years of age or \>2% reduction in BMI for patients \<18 years of age * History of major surgical procedure within 30 days * HbA1c \>10.9% * Fasting glucose level \>270 mg/dL * Previous use of MC4R agonists * Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET). * Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior * History or close family history of skin cancer or melanoma * Current clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

acquired hypothalamic obesity Sexual Infantilism

As listed by the trial registrant

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

Hypothalamic obesity

Contacts and locations

Locations

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham, B15 2TG, United Kingdom

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Columbia University

    New York, New York, 10027, United States

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH, United Kingdom

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University of Cambridge

    Cambridge, CB2 1TN, United Kingdom

  • University of Iowa Children's Hospital

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.