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Cagrilintide B

Phase 1

Overweight | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07605052A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body WeightPHASE1 NOT YET_RECRUITING 50May 20, 2026Sep 3, 2026May 22, 20261 United States
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Study Endpoints
Primary Endpoints
AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide
From Pre-dose at Day 29 to Day 36

Measured as hour\*nanomole per liter (h\*nmol/L).

Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide
From Pre-dose at Day 29 to Day 36

Measured as nanomole per liter (nmol/L).

Secondary Endpoints
AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide
From Pre-dose at Day 22 to Day 29
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide
From Pre-dose at Day 22 to Day 29
AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide
From Pre-dose at Day 1 to Day 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cagrilintide BEXPERIMENTALParticipants will receive cagrilintide B subcutaneously once weekly for 5 weeks.
Cagrilintide DEXPERIMENTALParticipants will receive cagrilintide D subcutaneously once weekly for 5 weeks.
Interventions
NameTypeDescription
Cagrilintide BDRUGCagrilintide B will be administered subcutaneously.
Cagrilintide DDRUGCagrilintide D will be administered subcutaneously.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Age 18-64 years (both inclusive) at the time of signing informed consent. * Male or female (sex assigned at birth). * Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose t...

Countries:United States
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