Safety and Tolerability
Conditions
Keywords
GLP-1/GLP-2 agonist, overweight, obesity
Brief summary
The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks for Part 1 and 28 weeks for Part 2. All subjects will be dosed for 13 weeks in Part 1 and for 28 weeks in Part 2 with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.
Detailed description
ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of ZP7570 and at steady state. The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits.
Interventions
DRUGZP7570
13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.
DRUGPlacebo
13 once-weekly subcutaneous injections in Part 1. 28 once-weekly subcutaneous injections in Part 2.
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Unblinding for Part 1 will be performed after completion of Part 1 (cohort 1-3) of the trial. Everyone involved in the conduct of Part 2 of the trial will be blinded until completion of Part 2 (cohort 4) of the trial and the final data review.
Intervention model description
The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts for Part 1 in a semi-parallel design and one cohort for Part 2.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 64 years, both inclusive. * Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive. * In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.
Exclusion criteria
* History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial. * Any relevant abnormal renal parameters in the following ranges: Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2 | Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127) in Part 1. Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 232) in Part 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics endpoints related to ZP7570 exposure | Area under the drug concentration curve from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2. | Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 18 weeks (Day 127) in Part 1. Pharmacokinetics: Area under the plasma concentration curve from baseline (Day 1, predose) to 33 weeks (Day 232) in Part 2. |
| Absolute change in body weight | Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2. | Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 92) in Part 1. Absolute change in body weight in kilogram (kg) from baseline (Day 1) to end of treatment (Day 197) in Part 2. |
| Percent change in body weight | Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2. | Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 92) in Part 1. Percent change in body weight in percent (%) from baseline (Day 1) to end of treatment (Day 197) in Part 2. |
Countries
Germany
Outcome results
None listed