CompletedPhase 1Results posted

Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.

A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Renal Function.

Lead sponsor

VectivBio AG

Asset

Apraglutide

Subcutaneous · GLP-2 receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Chronic kidney disease, Renal impairment

Eligibility highlights

•BMI 17.5-40•eGFR ≥90•Healthy volunteers

Primary endpoints

•Cmax of Apraglutide•AUC

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04699032

Org study IDTA799-014

Timeline

Milestones

Study start2020-12-08actual

Study first posted2021-01-07actual

Primary completion2021-07-05actual

Study completion2021-07-05actual

Results first posted2023-05-15actual

Last update posted2024-10-26actual

Assets

Investigational agents

Apraglutide

Who this study enrolls

Chronic kidney diseaseRenal impairment

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

All Participants

•Age between 18 and 75 years inclusive

•Subjects who are willing and able to comply with the study procedures

•Subjects able to understand and willing to sign the informed consent

•Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight of >50 kg (110 lb).

•Women of childbearing potential (WOCBP) on highly effective method of contraception during the trial and for 1 month after the end of trial (EOT) visit. Sterilized or infertile or postmenopausal females.

•Male subjects with a female partner of childbearing potential: highly effective methods of contraception and no sperm donation during the trial and for 1 month after (EOT) visit.

Healthy participants

•No clinically relevant abnormalities (medical history, vital signs, ECG, safety labs)

•eGFR measured by CKD-EPI ≥90 mL/min/1.73 m2) at two screening visits

•Demographically comparable to the group of subjects with impaired renal function:

Participants with impaired renal function

•Severe renal impairment: eGFR <30 mL/min/1.73 m2, but not requiring hemodialysis

•Moderate renal impairment: eGFR ≥30 mL/min/1.73 m2 and <60 mL/min/1.73 m2

•Mild renal impairment: eGFR ≥60 and <90 mL/min/1.73 m2

Exclusion criteria

All Subjects

•Renal transplant recipients

•History of systemic infection

•Any active malignancies or history of malignancies within the past 2 years

•Acute or chronic medical or psychiatric condition

•Treatment with an IMP within 30 days or 5 half-lives (whichever is longer) preceding the dose of IMP

•Male subjects partners of WOCBP who are unable to comply with the contraceptive measures

•History of clinically significant intestinal adhesions and/or chronic abdominal pain

•History of known colon polyps or family history of familial adenomatous polyposis

•Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV)-1 and -2 antibodies

•Serum albumin concentration <25 g/L (2.5 g/dL)

•Hemoglobin concentration <90 g/L (9.0 g/dL)

•Aspartate amino transaminase (AST) or alanine amino transaminase (ALT) values >2 × upper limit of normal (ULN)

•Proteinuria of >3 g total bilirubin >1.5 × ULN

•Positive urine test for alcohol or illicit drugs at either Screening or admission.

•Clinically significant abnormalities on 12-lead ECG

•Use of prescription or non-prescription drugs and dietary supplements within 7 days or five half-lives (whichever is longer) prior to Day 1. Stable concomitant medications may be given to subjects with renal impairment, if they are considered necessary for the welfare of the subjects.

•History of regular alcohol consumption exceeding seven drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine, or 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 3 months of Screening

•Female subjects of childbearing potential who are unwilling or unable to use highly effective methods of contraception for the duration of the trial and for at least 1 month after the administration of the IMP; pregnant female subjects; female subjects planning to become pregnant during the duration of the trial and until 1 month after the administration of the IMP; breastfeeding female subjects

•Blood donation of approximately 500 mL or more within 60 days prior to the dose of IMP. Plasma donations of approximately 500 mL or more within 28 days prior to the dose of IMP

Additional Exclusion Criteria for Healthy Subjects with Normal Renal Function

•Evidence or history of clinically significant abnormalities

•Evidence or history of clinically significant dermatological condition

Additional Exclusion Criteria for Subjects with Impaired Renal Function

•Subjects requiring hemodialysis and/or peritoneal dialysis

•Subjects with other clinically significant disease

•Subjects with any significant hepatic, cardiac, or pulmonary disease or subjects who are clinically nephrotic. Hypertension, diabetes mellitus, hyperparathyroidism, ischemic heart disease are not cause for exclusion as long as the subject is medically stable and any drugs that are administered for these conditions are not expected to interfere with the PK of apraglutide.

•Screening BP ≥180 mmHg (systolic) or ≥110 mmHg (diastolic)

Endpoints (8)

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

8 endpoints

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax) of Apraglutide

Time frame:5 minutes pre-dose up to 240 hours after dosing on Day 1

concentration, descriptive

Primary/registry result

Maximum Plasma Concentration (Cmax) of Apraglutide

Time frame:5 minutes pre-dose up to 240 hours after dosing on Day 1

concentration, descriptive

Posted result

Group	Mean · ng/mL	95% CI
Severely Impaired Renal Function	39.5	-
Normal Renal Function	65.8	-

Geometric least-square mean ratio0.62090% CI0.423 - 0.909

Primary/protocol endpoint

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide

Time frame:5 minutes pre-dose up to 240 hours after dosing on Day 1

concentration, descriptive

Primary/registry result

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide

Time frame:5 minutes pre-dose up to 240 hours after dosing on Day 1

concentration, descriptive

Posted result

Group	Mean · h*ng/mL	95% CI
Severely Impaired Renal Function	3330	-
Normal Renal Function	5050	-

Geometric least-square mean ratio0.69490% CI0.458 - 1.050

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 up to Day 14

event count, event

Secondary/registry result

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 up to Day 14

event count, event

Posted result

Group	Participants	95% CI
Severely Impaired Renal Function	3	-
Normal Renal Function	2	-

Secondary/protocol endpoint

Number of TEAEs

Time frame:Day 1 up to Day 14

event count, event

Secondary/registry result

Number of TEAEs

Time frame:Day 1 up to Day 14

event count, event

Posted result

Group	Number · events	95% CI
Severely Impaired Renal FunctionAny TEAEs	7	-
Any Mild TEAEs	4	-
Any Moderate TEAEs	3	-
Any Severe TEAEs	0	-
Any Treatment-Related TEAEs	5	-
Any Serious TEAEs	0	-
Any TEAEs leading to study discontinuation	0	-
Normal Renal FunctionAny TEAEs	3	-
Any Mild TEAEs	1	-
Any Moderate TEAEs	2	-
Any Severe TEAEs	0	-
Any Treatment-Related TEAEs	0	-
Any Serious TEAEs	0	-
Any TEAEs leading to study discontinuation	0	-

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

Greig G, Youssef NN, Bolognani F. Pharmacokinetics and Tolerability of a Single Dose of Apraglutide, a Novel, Long-Acting, Synthetic glucagon-like peptide-2 Analog With a Unique Pharmacologic Profile, in Individuals With Impaired Renal Function. J Clin Pharmacol. 2024 Jun;64(6):744-754. doi: 10.1002/jcph.2423. Epub 2024 Mar 11.
PMID38465515via clinicaltrials gov reference derived

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 November 5, 2026 snapshot.