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Hope for hypothalamic obesity: daily shot targets weight and hunger

NCT ID NCT06760546

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a daily injection of setmelanotide can help people aged 4 and older with hypothalamic obesity lose weight and feel less hungry. Participants will receive either the drug or a placebo for 26 weeks. The study aims to see if the treatment leads to meaningful reductions in body mass index (BMI) and improves quality of life.

What this could mean

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

Active substance

Setmelanotide (also known as Imcivree), a daily injection

What this could lead to

If it works, this could offer a new treatment option to help control weight and reduce hunger in people with hypothalamic obesity.

What could go wrong

This is a small, early-phase 3 trial with only 39 participants. The drug may not work better than placebo, and side effects from daily injections are possible.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

acquired hypothalamic obesity combined pituitary hormone deficiencies, genetic form isolated optic nerve hypoplasia non-acquired combined pituitary hormone deficiency Optic Nerve Hypoplasia pituitary stalk interruption syndrome septooptic dysplasia Sexual Infantilism

As listed by the trial registrant

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

CHILDHOOD-ONSET COMBINED PITUITARY HORMONE DEFICIENCY HYPOTHALAMIC OBESITY MULTIPLE PITUITARY HORMONE DEFICIENCY GENETIC FORM OPTIC NERVE HYPOPLASIA PITUITARY STALK INTERRUPTION SYNDROME SEPTO-OPTIC DYSPLASIA

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Birmingham Women and Children's Hospital NHS Trust

    RECRUITING

    Birmingham, West Midlands, B46NH, United Kingdom

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Minnesota

    RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Hull Royal Infirmary

    RECRUITING

    Hull, HU32RW, United Kingdom

  • Lurie Children's Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Seattle Children's Research Institute

    RECRUITING

    Seattle, Washington, 98105, United States

  • UCL Great Ormond Street Institute of Child Health

    RECRUITING

    London, Greater London, WC1N 1EH, United Kingdom

  • University of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States