A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2025-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Safety and Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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ZP7570

ZP7570 for subcutaneous once-weekly injection.

Group Type ACTIVE_COMPARATOR

ZP7570

Intervention Type DRUG

13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Placebo

Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Interventions

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ZP7570

13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Intervention Type DRUG

Placebo

13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.

Intervention Type DRUG

Other Intervention Names

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GLP-1/GLP-2 agonist

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 64 years, both inclusive.
* Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive.
* In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.

Exclusion Criteria

* History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial.
* Any relevant abnormal renal parameters in the following ranges:

Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes