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New obesity drug candidate monlunabant passes first safety check in healthy men

NCT ID NCT06542536

Knowledge-focused Sponsor: Novo Nordisk A/S 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial tested a single oral dose of monlunabant in 73 healthy Japanese and Caucasian men of normal weight. The main goal was to check safety and how the drug moves through the body. Participants received either monlunabant, placebo, or both, and were monitored for about 49 days. The study provides early safety data for this potential obesity treatment.

What this could mean

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

Active substance
monlunabant
What this could lead to
If successful, this could support further development of monlunabant as a potential treatment for obesity.
What could go wrong
This is an early Phase 1 safety study in healthy men, not designed to test weight loss. Results may not predict effectiveness in people with obesity.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

73 people

The number who actually took part.

Started

Aug 2024

Finished

Oct 2024

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

18 to 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: * Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * For Japanese participants, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent. * For Caucasian participants, self-reported European descent or white Latin-American descent. * BMI 18.5-24.9 kg/m\^2 (both inclusive) at screening. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Previous randomisation in this study. * Previous rescreening for this study. * History of Major Depressive Disorder within the last 2 years from screening. * Presence or history of any psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, depression, and anxiety) as judged by the investigator. * Suicidal ideation corresponding to type 4 or 5 or suicidal behaviour on the Columbia-Suicide Severity Rating Scale (C-SSRS) as assessed at screening or any history of suicidal attempts. * A Patient Health Questionnaire 9 (PHQ-9) score greater than 9 as assessed at screening.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

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

Obesity

Contacts and locations

Locations

  • Altasciences Clinical LA, Inc.

    Cypress, California, 90630, United States

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