A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
12 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
88
Estágio
- Fase inicial 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Regulatory Affairs Department Regulatory Affairs Department, MDRA
- Número de telefone: +49213140180
- E-mail: clinicaltrialservices@profil.com
Estude backup de contato
- Nome: Regulatory Affairs Department Regulatory Affairs Department
- Número de telefone: +49213140180
- E-mail: clinicaltrialservices@profil.com
Locais de estudo
-
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North Rhine-Westphalia
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Neuss, North Rhine-Westphalia, Alemanha, 41460
- Recrutamento
- Profil, Institut für Stoffwechselforschung GmbH
-
Contato:
- Regulatory Affairs Department Regulatory Affairs Department
- Número de telefone: +49213140180
- E-mail: clinicaltrialservices@profil.com
-
Contato:
- Project Management Project Management
- Número de telefone: +49213140180
- E-mail: clinicaltrialservices@profil.com
-
Investigador principal:
- Ulrike Hövelmann, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
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Comparador de 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety and Tolerability
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
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Trough concentration measured predose for MAD cohorts (Cτ)
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ulrike Hövelmann, Profil Institut für Stoffwechselforschung GmbH
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de julho de 2026
Conclusão Primária (Estimado)
6 de setembro de 2027
Conclusão do estudo (Estimado)
6 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2026
Primeira postagem (Real)
23 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ZP6590-26033
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Informações sobre medicamentos e dispositivos, documentos de estudo
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