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A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity

22 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

88

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Germania
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Germania, 41460
        • Reclutamento
        • Profil, Institut für Stoffwechselforschung GmbH
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Ulrike Hövelmann, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
Droga: ZP6590, solution for injection
Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
Comparatore placebo: Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
Droga: Placebo, solution for injection
Participants will receive single or multiple subcutaneous dose administrations of Placebo.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and Tolerability
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zealand Pharma

Investigatori

  • Investigatore principale: Ulrike Hövelmann, Profil Institut für Stoffwechselforschung GmbH

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

9 luglio 2026

Completamento primario (Stimato)

6 settembre 2027

Completamento dello studio (Stimato)

6 settembre 2027

Date di iscrizione allo studio

Primo inviato

16 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ZP6590-26033

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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