A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
12 août 2026 mis à jour par: Zealand Pharma
A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:
- Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?
- How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?
In the first Part of the study:
Participants will:
• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
In the second Part of the study:
Participants will:
• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit.
SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing.
Safety evaluation for dose escalation:
The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.
Type d'étude
Interventionnel
Inscription (Estimé)
88
Phase
- Première phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Regulatory Affairs Department Regulatory Affairs Department, MDRA
- Numéro de téléphone: +49213140180
- E-mail: clinicaltrialservices@profil.com
Sauvegarde des contacts de l'étude
- Nom: Regulatory Affairs Department Regulatory Affairs Department
- Numéro de téléphone: +49213140180
- E-mail: clinicaltrialservices@profil.com
Lieux d'étude
-
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North Rhine-Westphalia
-
Neuss, North Rhine-Westphalia, Allemagne, 41460
- Recrutement
- Profil, Institut für Stoffwechselforschung GmbH
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Contact:
- Regulatory Affairs Department Regulatory Affairs Department
- Numéro de téléphone: +49213140180
- E-mail: clinicaltrialservices@profil.com
-
Contact:
- Project Management Project Management
- Numéro de téléphone: +49213140180
- E-mail: clinicaltrialservices@profil.com
-
Chercheur principal:
- Ulrike Hövelmann, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
SAD-Part:
- Male participant
- Age between 18 and 55 years, both inclusive
- Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, both inclusive
MAD-Part:
- Male participant
- Age between 18 and 60 years, both inclusive
- Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
Exclusion Criteria:
SAD-Part and MAD-Part:
- Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator
- Treatment for weight management within 3 months before randomization in this trial
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
|
Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
|
|
Comparateur placebo: Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
|
Participants will receive single or multiple subcutaneous dose administrations of Placebo.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety and Tolerability
Délai: Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
|
Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
SAD Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
Peak Plasma Concentration (Cmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
Time to Peak Plasma Concentration (Tmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
Terminal rate constant (λz)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
Terminal half-life (t½)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
Apparent volume of distribution during terminal phase (Vz/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Délai: SAD-Part: From Day 1 to Day 29
|
apparent total clearance of ZP6590 from plasma for SAD cohorts (CL/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
Area under the plasma concentration versus time curve from 0 to trough (AUCτ)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
Trough concentration measured predose for MAD cohorts (Cτ)
|
MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal rate constant (λz)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal half-life (t½)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent volume of distribution during terminal phase (Vz/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent total clearance of ZP6590 from plasma at steady state (SS) for MAD-cohorts (CLss/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Délai: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Mean residence time of plasma ZP6590 concentration at steady state (SS) for MAD cohorts (MRTss)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ulrike Hövelmann, Profil Institut für Stoffwechselforschung GmbH
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 juillet 2026
Achèvement primaire (Estimé)
6 septembre 2027
Achèvement de l'étude (Estimé)
6 septembre 2027
Dates d'inscription aux études
Première soumission
16 juillet 2026
Première soumission répondant aux critères de contrôle qualité
22 juillet 2026
Première publication (Réel)
23 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZP6590-26033
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
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