Status
Completed
Phase
Phase 1
Enrollment
68
Locations
1
Results
Not posted
Publications
0
Study summary
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
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics). The trial is divided in two parts: Part 1: 20 Participants will receive 6 once-weekly doses as an injection under the skin (subcutaneous, s.c.). Participants will have 14 visits with the study team. 6 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 116 days. Part 2: 48 Participants will receive 16 once-weekly doses as an injection under the skin (subcutaneous, s.c.) in a dose up-titration dose scheme. Participants will have 23 or 24 visits with the study team. 13 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 198 days.
Interventions
DRUG
Part 1: Participants will receive 6 once-weekly doses of ZP8396 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort. Part 2: Participants will receive 16 once-weekly doses of ZP8396 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort. Dose up-titration will be used.
DRUG
Part 1: Participants will receive 6 once-weekly doses of placebo given subcutaneously (s.c., under the skin). Part 2: Participants will receive 16 once-weekly doses of placebo given subcutaneously (s.c., under the skin).
Timeline
First posted
Nov 14, 2022
Study start
Nov 7, 2022
Primary completion
Jun 13, 2024
Study completion
Jun 13, 2024
Results posted
Not reported
Registry updated
Jun 18, 2024
Outcomes
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)
Incidence of TEAEs from 1st dosing day to end of trial
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
Area under the plasma concentration-time curve over a dosing interval. Samples will be taken at set time points throughout the trial.
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
Area under the plasma concentration-time curve from time zero to infinity. Samples will be taken at set time points throughout the trial.
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
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.
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
Maximum (peak) plasma drug concentration
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
Time to reach maximum (peak) plasma concentration
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
Elimination rate constant
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
Elimination half-life
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
Apparent volume of distribution
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
Apparent total clearance of the drug from plasma
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
Trough concentration measured pre-dose
Eligibility
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
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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