CompletedPhase 1

Evaluation of Apraglutide on Gastric Emptying

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Center, Multiple-Dose, Parallel Trial Evaluating the Impact of Apraglutide on Gastric Emptying of Liquids in Healthy Subjects

Lead sponsor

VectivBio AG

Asset

Apraglutide

Subcutaneous · GLP-2 receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18-30

Primary endpoints

•Cmax of acetaminophen•Time at which the Cmax is observed (tmax) of acetaminophen•AUC of acetaminophen

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 IDNCT05995704

Org study IDTA799-020

Timeline

Milestones

Study start2023-03-02actual

Primary completion2023-07-24actual

Study completion2023-07-24actual

Study first posted2023-08-16actual

Last update posted2024-10-24actual

Assets

Investigational agents

Apraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age between 18 and 45 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 ≥18.0 to ≤30.0 kg/m2; and a total body weight of >50 kg (110 lb).

•Women of childbearing potential (WOCBP) having undergone bilateral tubal occlusion or with vasectomized partner. Sterilized or infertile or postmenopausal females.

•Male subjects with a WOCBP partner using highly effective methods of contraception and agreeing on no sperm donation during the trial and for 2 weeks after (EOT) visit.

Exclusion criteria

•History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease

•Known hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same class

•If capable of reproduction, unwilling to use an effective form of contraception

•If a WOCBP, a positive urine/blood pregnancy test

•Breast-feeding women

•Positive urine/blood test for alcohol and drugs of abuse

•Use of prohibited medications or herbal remedies

•Known presence or history of intestinal polyps

•Known presence or history of any type of cancer

•Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0×upper limit of normal range)

•Participation in an investigational drug or device study within 30 days prior to Screening

•Donation of blood over 500 mL within 2 months prior to Screening

•Use of tobacco products (i.e., smokes more than 5 cigarettes per day or equivalent)

•Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial

•Any intercurrent clinically significant illness in the previous 28 days before Day 1 of this study

•Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV IGM), hepatitis B surface antigen (HBsAgB), or hepatitis C virus (HCV)

•Unwillingness or inability to comply with the study protocol for any other reason

Endpoints (21)

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

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Weight

Time frame:Through study completion, up to 24 days

descriptive

Safety / tolerability / PK

14 endpoints

Primary/protocol endpoint

Maximum plasma concentration (Cmax) of acetaminophen

Time frame:0-300 Minutes

concentration, descriptive

Primary/protocol endpoint

Time at which the maximum plasma concentration is observed (tmax) of acetaminophen

Time frame:0-300 Minutes

concentration, descriptive

Primary/protocol endpoint

Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)

Time frame:0-14 hours

concentration, descriptive

Primary/protocol endpoint

Area under the acetaminophen concentration-time curve: AUC0-300min

Time frame:0-300 Minutes

concentration, descriptive

Primary/protocol endpoint

Area under the acetaminophen concentration-time curve: AUC0-60min

Time frame:0-60 Minutes

concentration, descriptive

Secondary/protocol endpoint

Physical examination

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

The incidence, nature and severity of adverse events (AEs) with apraglutide

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Anti-drug antibodies (ADA) analysis

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in vital signs

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in vital signs

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Through study completion, up to 24 days

descriptive

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Height

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint/low confidence

Clinical chemistry

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint/low confidence

Hematology

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint/low confidence

Hemostasis

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint/low confidence

Urine analysis

Time frame:Through study completion, up to 24 days

descriptive

Secondary/protocol endpoint/low confidence

Changes in body temperature in °C

Time frame:Through study completion, up to 24 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.