ObesityPhase 1NCT06542536
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
A Phase 1 study testing Monlunabant in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Monlunabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 25 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical LA, Inc.
Cypress, California, 90630
About this study
Official title: Investigation of Tolerability, Safety, and Pharmacokinetic Properties of a Single Oral Dose of Monlunabant in Male Japanese and Caucasian Participants With Normal Body Weight
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
- Being tested
- Monlunabant, Placebo (monlunabant)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonlunabantDrug
Oral monlunabant
Placebo (monlunabant)Drug
Oral placebo (monlunabant)
| Study group | Role | What they receive |
|---|---|---|
| Monlunabant dose 1 | Experimental | Dose 1 of monlunabant treatment Receives: Drug: Monlunabant |
| Monlunabant dose 2 | Experimental | Dose 2 of monlunabant treatment Receives: Drug: Monlunabant |
| Monlunabant dose 3 | Experimental | Dose 3 of the monlunabant treatment Receives: Drug: Monlunabant |
| Placebo (monlunabant) | Placebo comparator | Placebo treatment Receives: Drug: Placebo (monlunabant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
Number of events
Measured: 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
h*nmol/L
Measured: 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
nmol/L
Measured: 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
h (hours)
Measured: 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
h (hours)
Measured: From pre-dose (day 1) to end of study visit (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start9 Aug 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542536
- Sponsor's protocol ID
- NN9440-7952
- Other IDs
- U1111-1299-1093
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Tolerability, Safety, and Pharmacokinetic Properties of a Single Oral Dose of Monlunabant in Male Japanese and Caucasian Participants With Normal Body Weight
- ClinicalTrials.gov ID
- NCT06542536
- Acronym / sponsor ID
- NN9440-7952
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monlunabant dose 1 | Experimental | Drug: MonlunabantDose 1 of monlunabant treatment |
| Monlunabant dose 2 | Experimental | Drug: MonlunabantDose 2 of monlunabant treatment |
| Monlunabant dose 3 | Experimental | Drug: MonlunabantDose 3 of the monlunabant treatment |
| Placebo (monlunabant) | Placebo comparator | Drug: Placebo (monlunabant)Placebo treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonlunabantOral monlunabant | Drug | Monlunabant dose 1, Monlunabant dose 2, Monlunabant dose 3 |
| Placebo (monlunabant)Oral placebo (monlunabant) | Drug | Placebo (monlunabant) |
Primary outcome
Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
Time frame: From dosing (day 1) to end of study visit (day 21)
Number of events
4 secondary outcomes
AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From pre-dose (day 1) to end of study visit (day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monlunabant in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant (time frame: From dosing (day 1) to end of study visit (day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.