A Research Study Investigating Safety and Concentration in the Blood After One Dose Tablet of the New Medicine Monlunabant in Healthy Weight Japanese and Caucasian Men
Completed · Phase 1 · Has a placebo group
Conditions studied: Obesity
In brief
The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.
Key facts
- Study ID
- NCT06542536
- Run by
- Novo Nordisk A/S
- People needed
- 73
- Starts
- 2024-08-09
- Expected to finish
- 2024-10-25
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Altasciences Clinical LA, Inc. — Cypress, California, United States
Full record on ClinicalTrials.gov
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