ObesityPhase 1NCT06568731
A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity
A Phase 1 study testing Danuglipron in people with Obesity, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese: how the study medicine, danuglipron, is taken up into the blood about the safety and tolerability of danuglipron The total number of weeks of the study… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Danuglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 18 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)
Who cannot join
- Evidence or history of any clinically significant medical conditions or laboratory abnormality
- Any condition possibly affecting drug absorption
- Known intolerance/hypersensitivity to a GLP-1R agonist
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:
- how the study medicine, danuglipron, is taken up into the blood
- about the safety and tolerability of danuglipron
The total number of weeks of the study is about 15 (about 4 months).
- Conditions
- Obesity
- Being tested
- Danuglipron
- Keywords
- Overweight, Obesity, Danuglipron, GLP-1, Overtly healthy
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanuglipronDrug
Also called PF-06882961
Danuglipron oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Participants will receive multiple doses of danuglipron Receives: Drug: Danuglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron
Measured: Predose to 24 hours post danuglipron administration
Steady-state maximum observed concentration (Cmax) for danuglipron
Measured: Predose to 24 hours post danuglipron administration
Steady-state time to reach maximum observed concentration (Tmax) for danuglipron
Measured: Predose to 24 hours post danuglipron administration
Secondary outcomes (5)
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
Measured: From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant clinical laboratory abnormalities
Measured: From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant vital sign abnormalities
Measured: From baseline up to 28-35 days post last dose taken
Change from baseline in body weight
Measured: From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant changes ECG abnormalities
Measured: From baseline up to 28-35 days post last dose taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start23 Aug 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568731
- Sponsor's protocol ID
- C3421069
- Other IDs
- NCT06568731
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT06568731
- Acronym / sponsor ID
- C3421069
- Conditions
- Obesity
- Keywords
- Overweight, Obesity, Danuglipron, GLP-1, Overtly healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 23 Aug 2024 (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.
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:
- how the study medicine, danuglipron, is taken up into the blood
- about the safety and tolerability of danuglipron
The total number of weeks of the study is about 15 (about 4 months).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: DanuglipronParticipants will receive multiple doses of danuglipron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)
Key exclusion criteria (3 listed)
- Evidence or history of any clinically significant medical conditions or laboratory abnormality
- Any condition possibly affecting drug absorption
- Known intolerance/hypersensitivity to a GLP-1R agonist
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 |
|---|---|---|
| DanuglipronAlso: PF-06882961Danuglipron oral tablets | Drug | Single Arm |
Primary outcome
Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron
Time frame: Predose to 24 hours post danuglipron administration
Steady-state maximum observed concentration (Cmax) for danuglipron
Time frame: Predose to 24 hours post danuglipron administration
Steady-state time to reach maximum observed concentration (Tmax) for danuglipron
Time frame: Predose to 24 hours post danuglipron administration
5 secondary outcomes
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant clinical laboratory abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant vital sign abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
Change from baseline in body weight
Time frame: From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant changes ECG abnormalities
Time frame: From baseline up to 28-35 days post last dose taken
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 20 Jan 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Obesity
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.
Pfizer CT.gov Call Center study director
Pfizer
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 Danuglipron in people with Obesity, run by Pfizer at 1 site in United States.
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 2 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 20 Jan 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 United States. 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?
Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron (time frame: Predose to 24 hours post danuglipron administration). The study lists 3 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 20 Jan 2025.