A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants

NCT ID: NCT05613387

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2024-06-13

Brief Summary

The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of ZP8396 or placebo

Detailed Description

The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).

The trial is divided in two parts:

Part 1: 20 Participants will receive 6 once-weekly doses as an injection under the skin (subcutaneous, s.c.). Participants will have 14 visits with the study team. 6 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 116 days.

Part 2: 48 Participants will receive 16 once-weekly doses as an injection under the skin (subcutaneous, s.c.) in a dose up-titration dose scheme. Participants will have 23 or 24 visits with the study team. 13 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 198 days.

Conditions

Overweight; Healthy Volunteers; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ZP8396

Part 1: 2 dose cohorts are planned with 10 subjects in each; 7 participants in each cohort will receive active treatment.

Part 2: 3 dose cohorts are planned with 16 subjects in each; 12 participants in each cohort will receive active treatment.

Group Type: EXPERIMENTAL

ZP8396

Intervention Type: DRUG

Part 1: Participants will receive 6 once-weekly doses of ZP8396 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort.

Part 2: Participants will receive 16 once-weekly doses of ZP8396 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort. Dose up-titration will be used.

Placebo (ZP8396)

Part 1: In each of the 2 dose cohorts, 3 subjects will receive placebo.

Part 2: In each of the 3 cohorts, 4 subjects will receive placebo.

Group Type: PLACEBO_COMPARATOR

Drug: Placebo (ZP8396)

Intervention Type: DRUG

Part 1: Participants will receive 6 once-weekly doses of placebo given subcutaneously (s.c., under the skin).

Part 2: Participants will receive 16 once-weekly doses of placebo given subcutaneously (s.c., under the skin).

Interventions

ZP8396

Part 1: Participants will receive 6 once-weekly doses of ZP8396 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort.

Part 2: Participants will receive 16 once-weekly doses of ZP8396 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort. Dose up-titration will be used.

Intervention Type: DRUG

Drug: Placebo (ZP8396)

Part 1: Participants will receive 6 once-weekly doses of placebo given subcutaneously (s.c., under the skin).

Part 2: Participants will receive 16 once-weekly doses of placebo given subcutaneously (s.c., under the skin).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Part 1:

• Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
• Glycosylated hemoglobin (HbA1c) below 5.7 percent

Part 2:

• Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
• Glycosylated hemoglobin (HbA1c) below 6.5 percent

Exclusion Criteria

Part 1:

• History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
• Systolic blood pressure below 90 mmHg or above 139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHg
• Symptoms of arterial hypotension

Part 2:

• History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
• Systolic blood pressure below 90 mmHg or above 159 mmHg and/or diastolic blood pressure below 50 mmHg or above 99 mmHg
• Symptoms of arterial hypotension

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zealand Pharma A/S

Role: STUDY_DIRECTOR

Zealand Pharma A/S

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

ZP8396-21038

Identifier Type: -

Identifier Source: org_study_id