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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516901-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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This is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. The trial will be conducted in participants with a BMI ≥ 27.0 kg/m2.
Dapiglutide is a dual Glucagon-like peptide-1-/Glucagon-like peptide-2 Receptor Agonist (GLP-1R/GLP-2RA) in clinical development for weight management. The purpose of this phase 1 trial is to compare pharmacokinetics (PK) of a single dose administration of 7.5 mg dapiglutide administered subcutaneously (s.c.) with two drug product concentrations, 10 mg/mL and 25 mg/mL and will be conducted in 30 participants with a body mass index (BMI) ≥ 27.0 kg/m2. The development of a drug product with higher drug concentration will facilitate investigation of a wider dose range of dapiglutide in the clinical development program of the compound. The PK profile of a weight management drug should be assessed in people with a wide range of BMI and with a BMI within the range of the target population as body weight is expected to influence PKs of dapiglutide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapiglutide 10 mg/mL | Experimental | Single dose, s.c. administration |
|
| Dapiglutide 25 mg/mL | Experimental | Single dose, s.c. administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapiglutide 7.5 mg | Drug | Single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide | Area under the dapiglutide plasma concentration-time curve from time zero to infinity after a single 7.5 mg dose of dapiglutide (AUC0-inf). | Trial Day 1 to 28 |
| To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide | Maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Cmax) | Trial Day 1 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Area under the dapiglutide plasma concentration-time curve from time zero to last measurable concentration after a single 7.5 mg dose of dapiglutide (AUC0-t) | Day 1 to 28 |
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide |
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Inclusion Criteria:
Exclusion Criteria:
Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing are not eligible to participate
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hoevelmann, MD | Profil, Neuss | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | North Rhine-Westphalia | 41460 | Germany |
The data collection and handling of clinical trial data at the trial site has been designed to limit the possibility of identifying trial subjects from their data. To this end, pseudonymised data will be used wherever possible and the collection of demographic information that could be used for re-identification of subjects will be restricted to the extent necessary for the conduct of this trial.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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This is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide.
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Time to maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Tmax) |
| Day 1 to 28 |
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Terminal elimination half-life for dapiglutide after a single 7.5 mg dose of dapiglutide (t½) | Day 1 to 28 |
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Elimination rate constant for dapiglutide after a single 7.5 mg dose of dapiglutide (λz) | Day 1 to 28 |
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Apparent clearance of dapiglutide after a single 7.5 mg dose of dapiglutide (CL/F) | Day 1 to 28 |
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Apparent volume of distribution during terminal phase of dapiglutide after a single 7.5 mg dose of dapiglutide (Vz/f) | Day 1 to 28 |
| To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide | Mean residence time of dapiglutide after a single 7.5 mg dose of dapiglutide (MRT) | Day 1 to 28 |
| To investigate the safety and tolerability of a single dose administration of 7.5 mg dapiglutide | Incidence of treatment emergent adverse events (TEAEs) from dosing (Day 1) to end of trial (Day 42). | Day 1 to 42 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |