A Pharmacokinetic Study of Petrelintide at Various Concentrations in Participants with Body Mass Index ≥27.0 kg/m2 for Weight Reduction
- Trial ID
- 2025-520598-38-00
- Protocol
- ZP8396-25041
- Sponsor
- Zealand Pharma A/S
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the pharmacokinetics of petrelintide administered at varying drug product concentrations in individuals with a body mass index of 27.0 kg/m² or greater. This assessment is conducted to characterize the relationship between concentration and systemic exposure in a specific weight-related population. There are no secondary objectives reported.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, identified within the age range of 19 to 30 years. This population includes vulnerable groups and is being evaluated in the context of weight reduction.
Plans and Procedures
This Phase 3 clinical trial utilizes a design to investigate the pharmacokinetics of petrelintide across different drug product concentrations in individuals with a body mass index of 27.0 kg/m2 or greater. The research methodology focuses on the metabolic processes of the substance in the context of weight reduction. The study sequence begins with a screening visit to determine eligibility based on the specified physiological criteria. Subsequent follow-up visits are conducted to monitor the pharmacological profile and physiological responses. The procedure concludes with an end-of-study visit. The total duration of the study is expected to span from November 2025 to July 2026. Participation may be subject to early termination based on predefined clinical criteria or safety protocols.
Treatment
Efficacy
The assessment of efficacy in this Phase 3 clinical trial focuses on the evaluation of weight reduction. The study protocol aims to measure changes in body mass to determine the therapeutic impact of the intervention.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Germany | Not Recruiting | 01 Nov 2025 | 48 |

