DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body

A Study Investigating the Pharmacokinetic Properties of Cagrilintide in Participants With Various Degrees of Hepatic Impairment and Assessing the Absolute Bioavailability of Subcutaneous Cagrilintide in Healthy Volunteers

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

4

Recruiting sites

—

Enrollment

32

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI 18.5-39.9

Primary endpoint

•Part

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 IDNCT05564104
Org study IDNN9838-4692
Secondary ID2022-000138-41
Secondary IDU1111-1271-9259World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-10-03actual
Study start2023-04-05actual
Primary completion2024-09-06actual
Study completion2024-12-19actual
Last update posted2025-12-12actual

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female.
•Part A: Aged 18-80 years (both inclusive) at the time of signing informed consent.
•Part B: Aged 18-60 years (both inclusive) at the time of signing informed consent.
•Part A: Body mass index (BMI) between 18.5-39.9 kilograms per meter square (kg/m^2) (both inclusive).
•Part B: BMI between 25-30 kg/m2 (both inclusive).
•Specific inclusion criterion only for Part A participants with hepatic impairment: Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.

Exclusion criteria

•Known or suspected hypersensitivity to study intervention(s) or related products.
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

Endpoints (15)

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.

Safety / tolerability / PK

15 endpoints
Primary/protocol endpoint

Part A: AUC 0-infinity (∞), single dose (SD), cagri: The area under the cagrilintide plasma concentration-time curve fromtime 0 to infinity after a single dose

Time frame:From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 840 hours (post dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part A: Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose

Time frame:From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part A: Tmax,SD,cagri: Time to maximum observed plasma cagrilintide concentration after a single dose

Time frame:From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)

Tmax

descriptive

Secondary/protocol endpoint

Part A: T½ SD,cagri:Terminal half-life for cagrilintide after a single dose

Time frame:From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 840 hours (post dose)

Half-life

descriptive

Secondary/protocol endpoint

Part A: CL/F SD,cagri:Apparent clearance of cagrilintide after a single dose

Time frame:From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 840 hours (post dose)

descriptive

Secondary/protocol endpoint

Part B: AUC0-∞,SD,cagri: The area under the cagrilintide plasma concentration-time curve from time 0 to infinity after a single dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint/low confidence

Part B: AUC0-last,SD,cagri: The area under the cagrilintide plasma concentration-time curve from time 0 to last quantifiable observation

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

concentration, descriptive

Secondary/protocol endpoint

Part B: Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part B: tmax,SD,cagri: Time to maximum observed plasma cagrilintide concentration after a single dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)

Tmax

descriptive

Secondary/protocol endpoint

Part B: t½ SD,cagri: Terminal half-life for cagrilintide after a single dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

Half-life

descriptive

Secondary/protocol endpoint

Part B: CL/F SD,cagri: Apparent clearance of cagrilintide after a single s.c. dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

descriptive

Secondary/protocol endpoint

Part B: CL SD,cagri: Apparent clearance of cagrilintide after a single i.v. dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

descriptive

Secondary/protocol endpoint

Part B: V z/F,cagri: Volume of distribution of cagrilintide after a single s.c. dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

descriptive

Secondary/protocol endpoint

Part B: V z,cagri: Volume of distribution of cagrilintide after a single i.v. dose

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

descriptive

Secondary/protocol endpoint

Part B: MRT SD,cagri: Mean residence time of cagrilintide

Time frame:From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.