Overweight and ObesityPhase 1NCT06758583
A Trial Comparing Pharmacokinetics, Safety and Tolerability of Two Subcutaneous Concentrations of Dapiglutide
A Phase 1 study testing Dapiglutide 7.5 mg in people with Overweight and Obesity, run by Zealand Pharma at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Dapiglutide 7.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 23 Dec 2024to 25 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 64 years, both inclusive,
- BMI >= 27.0 kg/m^2
- HbA1c < 6.5 %.
Who cannot join
- Any history or presence of a disorder or a disease, which, in the investigator's opinion, might jeopardize participant's safety, evaluation of results or compliance with the protocol, treatment with dapiglutide (any exposure) or any other drugs, including dual and tri agonists, involving a GLP-1 RA or GLP-2 RA within 180 days prior to screening.
- Any medication (prescription and non-prescription drugs) with the exception of stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy.
- Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing
Trial locations and contacts
1 site in 1 country.
Germany1 site
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
About this study
Official title: An Open-label, Randomized, Parallel-group, Single-center Trial to Compare Pharmacokinetics of Dapiglutide After a Single Subcutaneous Dose of the Drug Product Concentrations 10 mg/mL or 25 mg/mL in Participants With Overweight or Obesity
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.
Read the detailed description
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.
- Conditions
- Overweight and Obesity
- Being tested
- Dapiglutide 7.5 mg
- Keywords
- GLP-1R/GLP-2RA, overweight, obesity, weight management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapiglutide 7.5 mgDrug
Single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Dapiglutide 10 mg/mL | Experimental | Single dose, s.c. administration Receives: Drug: Dapiglutide 7.5 mg |
| Dapiglutide 25 mg/mL | Experimental | Single dose, s.c. administration Receives: Drug: Dapiglutide 7.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Trial Day 1 to 28
Secondary outcomes (8)
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)
Measured: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time to maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Tmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Day 1 to 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start23 Dec 2024
- Primary completion12 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Ulrike Hoevelmann, MD, Principal investigator, Profil, Neuss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758583
- Sponsor's protocol ID
- ZP7570-24026
- Other IDs
- 2024-516901-21
- Status last verified
- May 2025
- First submitted
- 9 Dec 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel-group, Single-center Trial to Compare Pharmacokinetics of Dapiglutide After a Single Subcutaneous Dose of the Drug Product Concentrations 10 mg/mL or 25 mg/mL in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06758583
- Acronym / sponsor ID
- ZP7570-24026
- Conditions
- Overweight and Obesity
- Keywords
- GLP-1R/GLP-2RA, overweight, obesity, weight management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 12 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dapiglutide 10 mg/mL | Experimental | Drug: Dapiglutide 7.5 mgSingle dose, s.c. administration |
| Dapiglutide 25 mg/mL | Experimental | Drug: Dapiglutide 7.5 mgSingle dose, s.c. administration |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 64 years, both inclusive,
- BMI >= 27.0 kg/m^2
- HbA1c < 6.5 %.
Key exclusion criteria (3 listed)
- Any history or presence of a disorder or a disease, which, in the investigator's opinion, might jeopardize participant's safety, evaluation of results or compliance with the protocol, treatment with dapiglutide (any exposure) or any other drugs, including dual and tri agonists, involving a GLP-1 RA or GLP-2 RA within 180 days prior to screening.
- Any medication (prescription and non-prescription drugs) with the exception of stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy.
- Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapiglutide 7.5 mgSingle dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. | Drug | Dapiglutide 10 mg/mL, Dapiglutide 25 mg/mL |
Primary outcome
To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide
Time frame: Trial Day 1 to 28
Area under the dapiglutide plasma concentration-time curve from time zero to infinity after a single 7.5 mg dose of dapiglutide (AUC0-inf).
To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide
Time frame: Trial Day 1 to 28
Maximum observed dapiglutide plasma concentration after a single 7.5 mg dose of dapiglutide (Cmax)
8 secondary outcomes
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To characterize the pharmacokinetic profiles of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 28
To investigate the safety and tolerability of a single dose administration of 7.5 mg dapiglutide
Time frame: Day 1 to 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Hoevelmann, MD principal investigator
Profil, Neuss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapiglutide 7.5 mg in people with Overweight and Obesity, run by Zealand Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare pharmacokinetics of a single dose administration of 7.5 mg dapiglutide (time frame: Trial Day 1 to 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.