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Monlunabant

Phase 1

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 18, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

Monlunabant · 1 trial · 1 indication

Phase 1 1
NCT06542536A Research Study Investigating Safety and Concentration in the Blood After One Dose Tablet of the New Medicine Monlunabant in Healthy Weight Japanese and Caucasian MenObesity
COMPLETED73 Analytics
PHASE1COMPLETED
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
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
From dosing (day 1) to end of study visit (day 21)

Number of events

Secondary Endpoints

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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monlunabant dose 1EXPERIMENTALDose 1 of monlunabant treatment
Monlunabant dose 2EXPERIMENTALDose 2 of monlunabant treatment
Monlunabant dose 3EXPERIMENTALDose 3 of the monlunabant treatment
Placebo (monlunabant)PLACEBO_COMPARATORPlacebo treatment

Interventions

NameTypeDescription
MonlunabantDRUGOral monlunabant
Placebo (monlunabant)DRUGOral placebo (monlunabant)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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,...

Countries:United States
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Frequently asked questions about Monlunabant

What is Monlunabant used for?

Monlunabant is an investigational small molecule being developed for obesity. It is a metabolic therapeutic currently in Phase 1 clinical development. The drug is being studied in healthy weight Japanese and Caucasian men to evaluate its safety and concentration in the blood after a single oral dose.

Who makes Monlunabant?

Monlunabant is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company is conducting clinical research on this investigational drug for the treatment of obesity.

What phase is Monlunabant in?

Monlunabant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, and the drug remains in early-stage clinical research for obesity.

What clinical trials is Monlunabant in?

Monlunabant has one completed clinical trial, NCT06542536, a Phase 1 study in the United States. The trial enrolled 73 healthy male volunteers, both Japanese and Caucasian, to investigate the safety and blood concentration of a single oral dose of Monlunabant.

Is Monlunabant FDA approved?

Monlunabant is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for obesity. The completed Phase 1 trial focused on safety and pharmacokinetics in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory review.