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Semaglutide Pen Injector

Phase 2

Diabetes type1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Aug 4, 2026

Target and mechanism

Molecular targetGLP1R
Target classAgonist
ModalitySmall molecule

Also known as Semaglutide Pen Injector [Ozempic]

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

Semaglutide Pen Injector · 3 trials · 6 indications

Phase 2 3
NCT06449625Semaglutide in Auto-HSCTIntestinal Mucositis
NOT YET_RECRUITING40 Analytics
NCT06411210Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity TreatmentDiabetes type1
RECRUITING54 Analytics
NCT05424003Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver TransplantNAFLD
RECRUITING50 Analytics
PHASE2NOT YET_RECRUITING
Semaglutide in Auto-HSCT
Intestinal MucositisUnlock trial analytics
PHASE2RECRUITING
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Diabetes type1Unlock trial analytics
PHASE2RECRUITING
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
NAFLDUnlock trial analytics

Study Endpoints

Primary Endpoints

gastrointestinal mucositis severity
from day of stem cell infusion (day 0) to week +3

mean severity grade (0-II)

Change in VAT/(VAT+SAT) from baseline to 12 months
baseline and 12 months

Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year.

Change in hepatic insulin resistance from baseline to 12 months
baseline and 12 months

Hepatic insulin resistance, measured by serum concentration of beta-hydroxybutyrate (surrogate marker of acetyl-CoA, which regulates gluconeogenesis), changes over 1 year.

Change in triglycerides from baseline to 12 months
baseline and 12 months

Change in triglycerides after a high-fat mixed meal tolerance test, expressed as the total Area Under the Curve (AUCTG) over 6 hours from baseline to 1 year.

Change in weight
Baseline to week 72

Weight measured in kilograms

Secondary Endpoints

CRP increment
from day of stem cell infusion (day 0) to week +3
Quality of life general
change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Quality of life - high-dose chemotherapy treatment specific
change from baseline (start of high-dose chemotherapy) to study week 9 and 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
SemaglutideACTIVE_COMPARATORSemaglutide active drug 0.25-0.5mg, once-weekly, injection
PlaceboPLACEBO_COMPARATORSemaglutide placebo, once-weekly, injection

Interventions

NameTypeDescription
Semaglutide Pen Injector [Ozempic]DRUGSemaglutide active drug
PlaceboDRUGsemaglutide placebo
Semaglutide Pen InjectorDRUGEscalated to 2.4mg or max tolerated dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma * Age ≥ 18 years * BMI ≥ 18.5 * ECOG performance status\* ≤ 2 * Literate in Danish and/or English Exclusion Criteria: * Diabetes * Inflammatory bowel disease * Previous or current gastro...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 4, 2026NCT06411210lastUpdatePostDate: changed
LOWAug 4, 2026NCT06411210lastUpdatePostDate: changed

Frequently asked questions about Semaglutide Pen Injector

What is Semaglutide Pen Injector used for?

Semaglutide Pen Injector is being studied for intestinal mucositis, type 1 diabetes, and nonalcoholic fatty liver disease (NAFLD). It is an investigational small molecule GLP-1 receptor agonist in Phase 2 clinical development for these metabolic and inflammatory conditions.

What does Semaglutide Pen Injector target?

Semaglutide Pen Injector targets the glucagon-like peptide-1 receptor (GLP1R) and acts as an agonist. By activating GLP1R, it mimics the action of the natural GLP-1 hormone, which is involved in glucose metabolism and appetite regulation.

Who makes Semaglutide Pen Injector?

Semaglutide Pen Injector is developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting Phase 2 clinical trials to evaluate the drug for multiple indications.

What phase is Semaglutide Pen Injector in?

Semaglutide Pen Injector is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The compound has received accelerated approval designation, indicating a potential pathway for expedited development.

What clinical trials is Semaglutide Pen Injector in?

Semaglutide Pen Injector is being evaluated in three Phase 2 trials: NCT05424003 for NAFLD, NCT06411210 for type 1 diabetes and obesity, and NCT06449625 for intestinal mucositis. All are randomized, double-blind, placebo-controlled studies with a combined enrollment of 144 participants.

Is Semaglutide Pen Injector the same as Ozempic?

Yes, Semaglutide Pen Injector is also known as Ozempic. The drug is being studied under the brand name Ozempic in clinical trials for conditions including NAFLD, type 1 diabetes, and intestinal mucositis.