This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with co-morbidities or related diseases. The goal is to learn how the same single dose of petrelintide, given using different concentrations, works in the body when given to participants with a BMI at, or above, 27kg/m2. The main questions it aims to answer are: 1. Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations? 2. Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations? Participants will: Visit the study center 10 times for tests and blood sampling (9 day ambulatory visits and 1 in-house visit of 4 consecutive days with sleeping 3 nights at the study center). Petrelintide will be given once as a single injection in a skin fold of the abdomen on Day 1. The participants will be monitored until approximately Day 50.
This is an open-label, single-center, randomized, parallel-group study designed to investigate the pharmacokinetic (PK) profiles, safety, and tolerability of a single dose administration of petrelintide administered subcutanously (SC) using 4 different drug product concentrations. The study will be conducted in participants who have a body mass index (BMI) ≥27.0 kg/m2, who will be stratified to 2 cohorts by BMI at randomization (≤38 vs \>38, with 40% cap in each group). Approximately 48 participants are needed for the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Solution administered with a syringe
Charité Research Organisation GmbH
Berlin, Germany
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Area under the petrelintide plasma concentration time curve from time zero to infinity after a single dose of petrelintide (AUC0-inf)
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Maximum observed plasma concentration (Cmax) from time zero to infinity after a single dose of petrelintide
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Area under the petrelintide plasma concentration time curve from time zero to last measurable concentration after a single dose of petrelintide (AUC0-t)
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Time to maximum observed petrelintide plasma concentration after a single dose of petrelintide (Tmax)
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Terminal elimination half-life for petrelintide after a single dose of petrelintide (t1/2)
Time frame: Day 1 - day 50 (+/- 2)
To investigate the Pharmacokinetics of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Apparent clearance of petrelintide after a single dose of petrelintide (CL/F)
Time frame: Day 1 - day 50 (+/- 2)
To investigate the safety and tolerability of a single dose administration of petrelintide administered subcutaneously using 4 different drug product concentrations in participants with overweight or obesity
Incidence of treatment-emergent adverse events (TEAEs) from dosing (Day 1) to end of follow-up
Time frame: Day 1 - day 50 (+/- 2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.