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

NCT06000891 | Terminated Phase 1

• 2 other identifiers: ZP7570-230122022-500614-26
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety and Tolerability

Keywords

GLP-1/GLP-2 agonist, overweight, obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Pharmacokinetics endpoints related to ZP7570 exposure

  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.

• Pharmacokinetics endpoints related to ZP7570 exposure

  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

  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

  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

  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.

Study Arms (2)

ZP7570

ACTIVE COMPARATOR

ZP7570 for subcutaneous once-weekly injection.

Drug: ZP7570

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ZP7570 DRUG

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

Also known as: GLP-1/GLP-2 agonist

ZP7570

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand Pharma: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrike Hoevelmann, MD

  Profil, Neuss, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: September 15, 2023
• Primary Completion: February 11, 2025
• Study Completion: March 21, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)