Renal ImpairmentPhase 1NCT04178447
Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function
A Phase 1 study testing Glepaglutide in people with Renal Impairment, run by Zealand Pharma at 3 sites in 2 countries.
Trial summary
This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Glepaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Dec 2019to 14 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects
- Able to understand and willing to sign the informed consent
- eGFR values as defined in in the arms
- Willing and able to comply with the study requirements
- Male and female subjects age 18 to 70 years (both inclusive) at the time of informed consent
- BMI 20.0 - 30.0 kg/m2 both inclusive
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- Must be willing to comply with the contraception, sperm-donation requirements, and study restrictions.
- Renally Impaired Subjects (in Addition)
- Subject has a stable disease, including disease(s) associated with renal impairment, under medical control (ie, no changes in medication within 30 days prior to study drug administration). Stable renal impairment, defined as no clinically significant change in disease status within 3 months before screening.
Who cannot join
- All Subjects
- Suspicion of hypersensitivity, intolerance, or allergy to glepaglutide
- History of alcohol or drug abuse
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, clinically significant abnormalities on 12-lead ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the study or the safety of the subject except for conditions associated with renal impairment in subjects with renal impairment
- Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
- Acute illness within 14 days prior to dosing unless mild in severity and approved by the Investigator and Sponsor's medical representative
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- Presence of active infection requiring antibiotics. Ingestion of alcohol within 72 hours prior to study drug administration and during PK sampling period including Follow-Up
- Participation in another investigational drug study within 30 days prior to study drug administration or exposure to more than three new investigational agents within 12 months prior to study drug administration
- Previous exposure to GLP-1, GLP-2, human growth hormone, somatostatin, or analogues thereof within 3 months prior to Screening. Use of dipeptidyl peptidase-4 inhibitors within 3 months prior to Screening
- Previous exposure to glepaglutide
- Donation or loss of more than 450 mL blood during the 3 months before the start of Screening
- Female subjects who are breastfeeding, pregnant, or planning to become pregnant during the study
- Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or human immunodeficiency virus antibodies (anti-HIV)-1/2, unless the absence of an active hepatitis B/C infection is confirmed by a polymerase chain reaction (PCR) test, at Screening
- Positive urine screen of drugs of abuse (if not due to concomitant medication) or alcohol breath test at Screening and/or Day -1
- Legal incapacity or limited legal capacity
- Renally Impaired Subjects (in Addition)
- Acute renal failure (as judged by the Investigator)
- Renal impairment requiring dialysis
- History of kidney transplant regardless of functionality
- Serum albumin concentration <25 g/L
- Haemoglobin concentration <100 g/L
- Medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) and competitors of renal tubular secretion (e.g., probenecid) within 60 days prior to study drug administration
- Subjects With Normal Renal Function (in Addition)
- Significant medical history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Hungary2 sites
Fázis I-es Klinikai Farmakológiai
Budapest, 1077
Szent Imre Egyetemi Oktatókórház
Budapest, 1115
Poland1 site
Specjalistyczne Centrum Medyczne - Prywatny Szpital
Krakow, 31-559
About this study
Official title: An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function
This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) equation.
- Conditions
- Renal Impairment
- Being tested
- Glepaglutide
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlepaglutideDrug
Also called ZP1848
Single dose of Glepaglutide 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ESRD subjects not on dialysis or severe RI | Experimental | subjects with eGFR <15 mL/min/1.73 m2) or (eGFR 15 to <30 mL/min/1.73 m2) Receives: Drug: Glepaglutide |
| Group 2: normal renal function | Experimental | subjects with eGFR ≥90 mL/min/1.73 m2 Receives: Drug: Glepaglutide |
| Group 3: moderate RI | Experimental | subjects with eGFR 30 to <60 mL/min/1.73 m2 Receives: Drug: Glepaglutide |
| Group 4: mild RI | Experimental | subjects with eGFR 60 to <90 mL/min/1.73 m2 Receives: Drug: Glepaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Variables
AUC0-168 area under the concentration-time curve (AUC) from time 0 to 168 hours
Cmax maximum observed plasma concentration
Measured: 11 days
Secondary outcomes (1)
Safety Variables
Number of subject with AE/SAE as a measure of safety and tolerability
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start10 Dec 2019
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- If only Part A will be conducted total subjects of 16 will be enrolled if Part B also will be conducted up to 48 subjects will be enrolled.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178447
- Sponsor's protocol ID
- ZP1848-18131
- Other IDs
- 2019-001466-15, 2019
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2019
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agersnap MA, Sonne K, Knudsen KM, Sulowicz W. Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment. Clin Pharmacokinet. 2023 Apr;62(4):645-651. doi: 10.1007/s40262-023-01215-9. Epub 2023 Feb 21.
PubMed 36811175
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT04178447
- Acronym / sponsor ID
- ZP1848-18131
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) equation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- If only Part A will be conducted total subjects of 16 will be enrolled if Part B also will be conducted up to 48 subjects will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Group 1: ESRD subjects not on dialysis or severe RI | Experimental | Drug: Glepaglutidesubjects with eGFR <15 mL/min/1.73 m2) or (eGFR 15 to <30 mL/min/1.73 m2) |
| Group 2: normal renal function | Experimental | Drug: Glepaglutidesubjects with eGFR ≥90 mL/min/1.73 m2 |
| Group 3: moderate RI | Experimental | Drug: Glepaglutidesubjects with eGFR 30 to <60 mL/min/1.73 m2 |
| Group 4: mild RI | Experimental | Drug: Glepaglutidesubjects with eGFR 60 to <90 mL/min/1.73 m2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects
- Renally Impaired Subjects (in Addition)
Key exclusion criteria (24 listed)
- All Subjects
- Suspicion of hypersensitivity, intolerance, or allergy to glepaglutide
- History of alcohol or drug abuse
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, clinically significant abnormalities on 12-lead ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the study or the safety of the subject except for conditions associated with renal impairment in subjects with renal impairment
- Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlepaglutideAlso: ZP1848Single dose of Glepaglutide 10 mg | Drug | Group 1: ESRD subjects not on dialysis or severe RI, Group 2: normal renal function, Group 3: moderate RI, Group 4: mild RI |
Primary outcome
Pharmacokinetic Variables
Time frame: 11 days
AUC0-168 area under the concentration-time curve (AUC) from time 0 to 168 hours Cmax maximum observed plasma concentration
1 secondary outcome
Safety Variables
Time frame: 11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 36811175Agersnap MA, Sonne K, Knudsen KM, Sulowicz W. Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment. Clin Pharmacokinet. 2023 Apr;62(4):645-651. doi: 10.1007/s40262-023-01215-9. Epub 2023 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glepaglutide in people with Renal Impairment, run by Zealand Pharma at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Variables (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.