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Semaglutide D Dose 1

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 19, 2024

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 Trials2
Total Enrollment930
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05227196A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy PeoplePHASE1 COMPLETED 546 — — Feb 4, 2022Aug 8, 2023Sep 19, 20243 United States, Canada
NCT05129891A Research Study Looking at New Protein-based Tablets in Healthy Male ParticipantsPHASE1 COMPLETED 384 — — Nov 3, 2021May 4, 2023May 29, 20242 Canada, Germany
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Study Endpoints
Primary Endpoints
AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

h∙nmol/L

Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

nmol/L

AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

h \* nmol/L

Secondary Endpoints
tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1 Sequence 1EXPERIMENTALCrossover arm
Group 1 Sequence 2EXPERIMENTALCrossover arm
Group 2 Sequence 1EXPERIMENTALCrossover arm
Group 2 Sequence 2EXPERIMENTALCrossover arm
Group 3 Sequence 1EXPERIMENTALCrossover arm
Group 3 Sequence 2EXPERIMENTALCrossover arm
Part A: Oral semaglutideEXPERIMENTALFour different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Part B: NNC0385-0434EXPERIMENTALFour different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
Interventions
NameTypeDescription
Semaglutide D Dose 1DRUGTablet given orally
Semaglutide D Dose 2DRUGTablet given orally
Semaglutide D Dose 3DRUGTablet given orally
Semaglutide Dose 4DRUGTablet given orally
Semaglutide Dose 5DRUGTablet given orally
Semaglutide Dose 6DRUGTablet given orally
Semaglutide DDRUGTablet given orally
Semaglutide GDRUGTablet given orally
Semaglutide HDRUGTablet given orally
Semaglutide IDRUGTablet given orally
NNC0385-0434 BDRUGTablet given orally
NNC0385-0434 CDRUGTablet given orally
NNC0385-0434 DDRUGTablet given orally
NNC0385-0434 EDRUGTablet given orally
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 kg/m\^2 (both inclusive). * Considered to be generally healthy based on the medical history, physical examination, and the results of vital ...

Countries:United StatesCanadaGermany
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