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

NCT06542536 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9440-7952U1111-1299-1093
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant

  Number of events

  From dosing (day 1) to end of study visit (day 21)

Secondary Outcomes (4)

• AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant

  From pre-dose (day 1) to end of study visit (day 21)

• Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant

  From pre-dose (day 1) to end of study visit (day 21)

• tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant

  From pre-dose (day 1) to end of study visit (day 21)

• t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant

  From pre-dose (day 1) to end of study visit (day 21)

Study Arms (4)

Monlunabant dose 1

EXPERIMENTAL

Dose 1 of monlunabant treatment

Drug: Monlunabant

Monlunabant dose 2

EXPERIMENTAL

Dose 2 of monlunabant treatment

Drug: Monlunabant

Monlunabant dose 3

EXPERIMENTAL

Dose 3 of the monlunabant treatment

Drug: Monlunabant

Placebo (monlunabant)

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo (monlunabant)

Interventions

Monlunabant DRUG

Oral monlunabant

Monlunabant dose 1; Monlunabant dose 2; Monlunabant dose 3

Placebo (monlunabant) DRUG

Oral placebo (monlunabant)

Placebo (monlunabant)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: August 9, 2024
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)