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Semaglutide D Dose 1

Phase 1

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

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment930

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

Semaglutide D Dose 1 · 3 trials · 4 indications

Phase 1 3
NCT05236517A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With ObesityObesity
COMPLETED60 Analytics
NCT05227196A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy PeopleHealthy Volunteers
COMPLETED546 Analytics
NCT05129891A Research Study Looking at New Protein-based Tablets in Healthy Male ParticipantsHealthy Volunteers
COMPLETED384 Analytics
PHASE1COMPLETED
A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
ObesityUnlock trial analytics
PHASE1COMPLETED
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative change in energy intake during ad libitum lunch
Baseline to Day 140

Measured in Percentage

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

Change in energy intake during ad libitum lunch
Baseline to Day 140
Change in amount of food consumed during ad libitum lunch
Baseline to Day 140
Change in body weight
Baseline to Day 141
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SemaglutideEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
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 C Dose 4DRUGTablet given orally
Semaglutide C Dose 5 (50 mg)DRUGTablet given orally
Placebo (Semaglutide C)DRUGTablet given orally
Placebo ( Semaglutide D)DRUGTablet 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 to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent * Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m\^2) (both inclusive) Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant o...

Countries:GermanyUnited StatesCanada
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Frequently asked questions about Semaglutide D Dose 1

What is Semaglutide D Dose 1 used for?

Semaglutide D Dose 1 is an investigational small molecule being developed by Novo Nordisk A/S for metabolic conditions, including obesity and healthy volunteer studies. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.

How does Semaglutide D Dose 1 work?

Semaglutide D Dose 1 is a small molecule developed for metabolic conditions. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not detailed here.

Who makes Semaglutide D Dose 1?

Semaglutide D Dose 1 is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy volunteers and people with obesity.

What phase is Semaglutide D Dose 1 in?

Semaglutide D Dose 1 is in Phase 1 clinical development. It is an investigational drug, meaning it is not FDA approved and is still being studied in clinical trials. The drug has received an accelerated approval designation, but this does not indicate it has been approved for commercial use.

What clinical trials is Semaglutide D Dose 1 in?

Semaglutide D Dose 1 has completed three Phase 1 trials: NCT05129891, NCT05227196, and NCT05236517. These studies evaluated the drug in healthy volunteers, people with type 2 diabetes, and individuals with obesity. All trials are completed, with a total enrollment of 930 participants across Canada, Germany, and the United States.

Is Semaglutide D Dose 1 the same as oral semaglutide?

Semaglutide D Dose 1 is a form of oral semaglutide, as indicated by clinical trial NCT05227196, which compares two different forms of oral semaglutide. However, the drug is distinct from other semaglutide formulations and is being studied specifically as a small molecule for metabolic conditions.