DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function

An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NNC0174-0833 in Subjects With Normal Renal Function and Impaired Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

2

Recruiting sites

—

Enrollment

33

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

—

Primary endpoint

•AUC of NNC0174-0833 after a single dose

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 IDNCT04209049
Org study IDNN9838-4518
Secondary IDU1111-1228-9001World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-12-23actual
Study start2020-01-15actual
Primary completion2021-01-05actual
Study completion2021-01-05actual
Last update posted2021-01-26actual

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female of non-childbearing potential, aged 18-80 years (both inclusive) at the time of signing informed consent.
•Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
•For subjects with normal renal function: eGFR of equal to or above 90 mL/min
•For patients with mild renal impairment: eGFR of 60-89 mL/min
•For patients with moderate renal impairment: eGFR of 30-59 mL/min
•For patients with severe renal impairment: eGFR of <30 mL/min not requiring dialysis

Exclusion criteria

•Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
•Use of prescription or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect subject safety or the results of the trial.

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

Area under the plasma NNC0174-0833 concentration-time curve after a single dose

Time frame:From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed plasma NNC0174-0833 concentration after a single dose

Time frame:From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed plasma NNC0174-0833 concentration after a single dose

Time frame:From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)

Tmax

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36)

Treatment-emergent AEs (any)

event count, event

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.