A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants

A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants

This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Healthy Volunteers
• Intervention / Treatment: Drug: CDR132L (s.c.); Drug: CDR132L (i.v.)

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Recruiting
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female (sex at birth).
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index 18.5-29.9 kilograms per square metre (kg/m^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1).
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.

Exclusion Criteria:

• Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.

  • Alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) +10 percentage (%)
  • Aspartate aminotransferase (AST) >ULN +20%
  • Bilirubin >ULN +20%
  • Creatinine >ULN +10%
  • Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) less than (<) 90 milliliters per minute/1.73square meter (mL/min/1.73m^2)
  • Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg/g)
• Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).
• Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
• Heart rate outside the range of 50-89 beats/minute at screening (visit 1).
• Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.
• Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin <90 grams per litre (g/L))
• Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.
• Presence of thrombocytopenia, defined as thrombocyte count <150 x 10^9 cells/L at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.
• Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously.	Drug: CDR132L (s.c.); CDR132L will be administered subcutaneously.; Drug: CDR132L (i.v.); CDR132L will be administered intravenously.
Experimental: Sequence B; Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously.	Drug: CDR132L (s.c.); CDR132L will be administered subcutaneously.; Drug: CDR132L (i.v.); CDR132L will be administered intravenously.
Experimental: Sequence C; Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously.	Drug: CDR132L (s.c.); CDR132L will be administered subcutaneously.; Drug: CDR132L (i.v.); CDR132L will be administered intravenously.
Experimental: Sequence D; Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously.	Drug: CDR132L (s.c.); CDR132L will be administered subcutaneously.; Drug: CDR132L (i.v.); CDR132L will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration	Measured as hours*nanograms per milliliter (h*ng/mL)	From 0 to 840 hours after CDR132L administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose	Measured as h*ng/mL	From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose	Measured as nanograms per milliliter (ng/mL)	From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose divided by dose	Measured as nanograms per milliliter per milligram (ng/mL/mg)	From 0 to 840 hours after CDR132L administration
Time to maximum observed CDR132L plasma concentration after a single dose	Measured in hours	From 0 to 840 hours after CDR132L administration
Terminal half-life for CDR132L after a single dose	Measured in hours	From 0 to 840 hours after CDR132L administration
Area under the CDR132L plasma concentration-time curve from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration, divided by dose	Measured as hours*nanograms per milliliter per milligram (h*ng/mL/mg)	From 0 to 840 hours after CDR132L administration
Total plasma clearance of CDR132L after a single dose	Measured as liters per hour	From 0 to 840 hours after CDR132L administration
Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values	Measured in liters	From 0 to 840 hours after CDR132L administration
Mean residence time for CDR132L after a single dose	Measured in hours	From 0 to 840 hours after CDR132L administration
Number of adverse events	Measured as number of events	From first CDR132L administration (day 1) to day 141

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: NN6706-8230; U1111-1319-6249 (Other Identifier: World Health Organization (WHO)); 2025-521329-34 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No