DelfaGLP-1 Atlas

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CompletedPhase 1

A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight

An Open-label, One-sequence Cross-over, Single-centre Trial, Investigating the Influence of CagriSema on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Atorvastatin in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

34

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-39.9

Primary endpoints

•AUC of atorvastatin from time 0•AUC of S-warfarin from time 0

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06289504
Org study IDNN9838-4694
Secondary IDU1111-1295-4056World Health Organization (WHO)

Timeline

Milestones

Study start2024-02-27actual
Study first posted2024-03-04actual
Primary completion2024-10-16actual
Study completion2024-11-15actual
Last update posted2026-05-19actual

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female.
•Aged 18-65 years (both inclusive) at the time of signing informed consent.
•Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion criteria

•Previous dosing in a study with an amylin analogue.
•Presence or history of pathological bleeding tendencies, recent serious bleeding, recent myopathy or rhabdomyolysis, malignant hypertension and any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions including type 1 or type 2 diabetes mellitus.
•Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
•Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
•Activated partial thromboplastin time (APTT) less than (<) 22.1 seconds (lower normal limit [LNL]-0%) or APTT greater than (>) 28.1 seconds (upper limit of normal [UNL) +0%) at screening.
•Prothrombin time < 70% (LNL-0%) or prothrombin time > 130% (UNL-0%) at screening.
•Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol and highly effective contraceptives.

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
20
Other (unclassified)
3

Safety / tolerability / PK

20 endpoints
Primary/protocol endpoint

AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state

Time frame:Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)

concentration, descriptive

Primary/protocol endpoint

AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state

Time frame:Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state

Time frame:Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state

Time frame:Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)

Tmax

descriptive

Secondary/protocol endpoint

AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Tmax

descriptive

Secondary/protocol endpoint

Rac,0-168hours,cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose

Time frame:Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose)

ratio, descriptive

Secondary/protocol endpoint

Rac,0-168hours,sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose

Time frame:Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose

ratio, descriptive

Secondary/protocol endpoint

AUC0-168hours, 4th dose cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema

Time frame:Day 44 (pre-dose to 168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema

Time frame:Day 44 (pre-dose to 168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-168hours, cagri 2.4mg, SS: Area under the cagrilintide plasma concentration curve from 0 to 168 hours at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-168hours, sema 2.4mg, SS: Area under the semaglutide plasma concentration curve from 0 to 168 hours at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, cagri, SS: Maximum observed cagrilintide plasma concentration at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, cagri, SS: Time to maximum observed cagrilintide plasma concentration at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

Tmax

concentration, descriptive

Secondary/protocol endpoint

Cmax, sema,SS: Maximum observed semaglutide plasma concentration at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, sema, SS: Time to maximum observed semaglutide plasma concentration at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

Tmax

descriptive

Secondary/protocol endpoint/low confidence

CL/Fcagri,SS: total apparent clearance of cagrilintide at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

descriptive

Secondary/protocol endpoint

CL/Fsema,SS: total apparent clearance of semaglutide at steady state

Time frame:Day 163 (pre-dose to 168 hours post-dose)

descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

descriptive

Secondary/protocol endpoint/low confidence

INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

ratio, descriptive

Secondary/protocol endpoint/low confidence

tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame:Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.