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

NCT05613387 | Completed Phase 1

• 1 other identifier: ZP8396-21038
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Healthy Volunteers; Obese

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events (TEAEs)

  Incidence of TEAEs from 1st dosing day to end of trial

  Part 1: From dosing (Day 1) to end of trial (Day 92); Part 2: From dosing (Day 1) to end of trial (Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)

Secondary Outcomes (28)

• Pharmacokinetics (PK) of ZP8396 (AUCτ)

  Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

• Pharmacokinetics (PK) of ZP8396 (AUCinf)

  Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

• Pharmacokinetics (PK) of ZP8396 (AUClast)

  Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

• Pharmacokinetics (PK) of ZP8396 (Cmax)

  Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

• Pharmacokinetics (PK) of ZP8396 (tmax)

  Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

Study Arms (2)

ZP8396

EXPERIMENTAL

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.

Drug: ZP8396

Placebo (ZP8396)

PLACEBO COMPARATOR

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.

Drug: Drug: Placebo (ZP8396)

Interventions

ZP8396 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.

ZP8396

Drug: Placebo (ZP8396) 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).

Placebo (ZP8396)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead

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

• Zealand Pharma A/S

  Zealand Pharma A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: A single-centre, placebo-controlled, double-blind (within cohorts), randomised multiple ascending dose trial. Part 2: A single-centre, placebo-controlled, double-blind (within cohorts), randomised multiple ascending dose trial, using dose up-titration.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 14, 2022
• Study Start: November 7, 2022
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)