Skip to content

Trial · Interventional

CompletedPhase 1Registry data

A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants

NCTNCT05613387 (opens ClinicalTrials.gov in a new tab)Other idZP8396-21038
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
68 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Germany

Start
7 Nov 2022
Primary completion
13 Jun 2024
Completion
13 Jun 2024
First posted
14 Nov 2022
Last update posted
18 Jun 2024
Conditions
Overweight · Healthy Volunteers · Obese

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 1

    A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants

    NCT05613387

    7 Nov 2022 to 13 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of ZP8396 or placebo

Interventions

  • ZP8396Drug
  • Drug: Placebo (ZP8396)Drug

Arms2

  • Experimental

    ZP8396

    Part 1: 2 dose cohorts are planned with 10 subjects in each; 7 participants in each cohort will receive active treatment. Part 2: 3 dose cohorts are planned with 16 subjects in each; 12 participants in each cohort will receive active treatment.

  • Placebo comparator

    Placebo (ZP8396)

    Part 1: In each of the 2 dose cohorts, 3 subjects will receive placebo. Part 2: In each of the 3 cohorts, 4 subjects will receive placebo.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame · Part 1: From dosing (Day 1) to end of trial (Day 92); Part 2: From dosing (Day 1) to end of trial (Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)

    Registry description

    Incidence of TEAEs from 1st dosing day to end of trial

Secondary outcomes(20)

  1. Pharmacokinetics (PK) of ZP8396 (AUCτ)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Area under the plasma concentration-time curve over a dosing interval. Samples will be taken at set time points throughout the trial.

  2. Pharmacokinetics (PK) of ZP8396 (AUCinf)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Area under the plasma concentration-time curve from time zero to infinity. Samples will be taken at set time points throughout the trial.

  3. Pharmacokinetics (PK) of ZP8396 (AUClast)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration. Samples will be taken at set time points throughout the trial.

  4. Pharmacokinetics (PK) of ZP8396 (Cmax)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Maximum (peak) plasma drug concentration

  5. Pharmacokinetics (PK) of ZP8396 (tmax)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Time to reach maximum (peak) plasma concentration

  6. Pharmacokinetics (PK) of ZP8396 (λz)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Elimination rate constant

  7. Pharmacokinetics (PK) of ZP8396 (t½)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Elimination half-life

  8. Pharmacokinetics (PK) of ZP8396 (Vz/f)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Apparent volume of distribution

  9. Pharmacokinetics (PK) of ZP8396 (CL/f)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Apparent total clearance of the drug from plasma

  10. Pharmacokinetics (PK) of ZP8396 (Ctrough)

    Time frame · Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

    Registry description

    Trough concentration measured pre-dose

  11. Accumulation Ratio for AUCτ

    Time frame · Part 1: Day 1 (pre-dose) to Day 92

    Registry description

    Accumulation Ratio for AUCτ

  12. Accumulation Ratio for Cmax

    Time frame · Part 1: Day 1 (pre-dose) to Day 92

    Registry description

    Accumulation Ratio for Cmax

  13. Pharmacodynamics (PD) of ZP8396 (Cmax acetaminophen)

    Time frame · Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  14. Pharmacodynamics (PD) of ZP8396 (Tmax acetaminophen)

    Time frame · Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  15. Pharmacodynamics (PD) of ZP8396 (AUCacetaminophen, 0-60 min)

    Time frame · Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  16. Pharmacodynamics (PD) of ZP8396 (AUCacetaminophen, 0-240 min)

    Time frame · Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  17. Pharmacodynamics (PD) of ZP8396 (Emax, Plasma Glucose [PG])

    Time frame · Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  18. Pharmacodynamics (PD) of ZP8396 (Tmax, Plasma Glucose [PG])

    Time frame · Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  19. Pharmacodynamics (PD) of ZP8396 (AUE, Plasma Glucose [PG], 0-60 minutes)

    Time frame · Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

  20. Pharmacodynamics (PD) of ZP8396 (AUE, Plasma Glucose [PG], 0-240 minutes)

    Time frame · Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

    Registry description

    Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Part 1: * Body Mass Index (BMI) between 21.0 and 29.9 kg/m\^2, both inclusive * Glycosylated hemoglobin (HbA1c) below 5.7 percent Further inclusion criteria apply Part 2: * Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive * Glycosylated hemoglobin (HbA1c) below 6.5 percent Further inclusion criteria apply Exclusion Criteria: Part 1: * History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke * Systolic blood pressure below 90 mmHg or above 139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHg * Symptoms of arterial hypotension Further exclusion criteria apply Part 2: * History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke * Systolic blood pressure below 90 mmHg or above 159 mmHg and/or diastolic blood pressure below 50 mmHg or above 99 mmHg * Symptoms of arterial hypotension Further exclusion criteria apply

PepBank is a research reference. Talk to a doctor before you use any peptide.