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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500614-26 | EudraCT Number |
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Decision by Sponsor; LSLV was completed on 21-Mar-2025 as planned.
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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks for Part 1 and 28 weeks for Part 2. All subjects will be dosed for 13 weeks in Part 1 and for 28 weeks in Part 2 with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.
ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of ZP7570 and at steady state.
The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP7570 | Active Comparator | ZP7570 for subcutaneous once-weekly injection. |
|
| Placebo | Placebo Comparator | Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZP7570 | Drug | 13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127) in Part 1. Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 232) in Part 2. | Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Area under the drug concentration curve from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
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Inclusion Criteria:
Exclusion Criteria:
Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.
2. Male subject or female subject of non-child-bearing potential A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hoevelmann, MD | Profil, Neuss, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | North Rhine-Westphalia | 41460 | Germany |
The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts for Part 1 in a semi-parallel design and one cohort for Part 2.
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Unblinding for Part 1 will be performed after completion of Part 1 (cohort 1-3) of the trial. Everyone involved in the conduct of Part 2 of the trial will be blinded until completion of Part 2 (cohort 4) of the trial and the final data review.
| Placebo | Drug | 13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2. |
|
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Maximum plasma concentration (peak) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Maximum drug concentration (Cmax) from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Time to maximum plasma concentration (Tmax) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Time to maximum plasma concentration from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Elimination rate constant (λz) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Elimination rate constant (λz) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Elimination rate constant from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Elimination half-life (t1/2) from baseline (Day 1, predose) to 22 weeks (Day 232) in Part 2. | Elimination half-life from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Apparent volume of distribution (Vz/f) during the terminal phase from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Apparent volume of distribution (Vz/f) during the terminal phase from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Apparent volume of distribution from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Apparent total clearance of the drug from plasma (Cl/f) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Apparent total clearance of the drug from plasma (Cl/f) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Apparent total clearance of the drug from plasma from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.) |
| Pharmacokinetics endpoints related to ZP7570 exposure | Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics - Trough concentration measured predose (Ctrough) from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. | Trough concentration measured from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. |
| Absolute change in body weight | Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 92) in Part 1. Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 197) in Part 2. | Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2. |
| Percent change in body weight | Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 92) in Part 1. Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 197) in Part 2. | Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |