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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Each participant will receive a single subcutaneous dose of petrelintide strength A on Day 1. |
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| Arm B | Active Comparator | Each participant will receive a single subcutaneous dose of petrelintide strength B on Day 1. |
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| Arm C | Active Comparator | Each participant will receive a single subcutaneous dose of petrelintide strength C on Day 1. |
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| Arm D | Active Comparator | Each participant will receive a single subcutaneous dose of petrelintide strength D on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Petrelintide | Drug | Solution administered with a syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Day 1 - day 50 (+/- 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 - day 50 (+/- 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Haidacher | Charité Research Organisation GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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) | 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) | 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) | 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 | Day 1 - day 50 (+/- 2) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |