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Semaglutide D Dose 1

Phase 1

High Blood Cholesterol Levels | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Sep 19, 2024

Semaglutide D Dose 1 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2022

Semaglutide D Dose 1 target and mechanism

Molecular targetGLP1R
Target classAgonist
ModalitySmall molecule

Also known as Semaglutide D

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment990

FDA Designations

No designations recorded

Semaglutide D Dose 1 clinical trials

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?

Semaglutide D Dose 1 is an investigational oral formulation of semaglutide being developed by Novo Nordisk A/S. It is a small molecule GLP-1 receptor agonist studied in Phase 1 clinical trials for obesity, type 2 diabetes, and high blood cholesterol levels. It has not been approved by the FDA and remains in clinical development.

What does Semaglutide D Dose 1 target?

Semaglutide D Dose 1 targets GLP1R, the glucagon-like peptide-1 receptor, and acts as a receptor agonist. By activating GLP1R, the drug mimics the action of the endogenous incretin hormone GLP-1, which is involved in regulating appetite, food intake, and glucose-dependent insulin secretion.

Who makes Semaglutide D Dose 1?

Semaglutide D Dose 1 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk is the sponsor of the Phase 1 clinical program evaluating this oral semaglutide formulation.

What phase is Semaglutide D Dose 1 in?

Semaglutide D Dose 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program has been completed, with no active trials currently listed for this specific formulation.

What clinical trials is Semaglutide D Dose 1 in?

Semaglutide D Dose 1 has been evaluated in Phase 1 trials including NCT05236517, which studied 50 mg semaglutide daily and its effects on food intake and stomach emptying in people with obesity, and NCT05227196, which compared two oral semaglutide forms in healthy participants and those with type 2 diabetes.