Overweight and/or ObesityPhase 1NCT07876531
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
A Phase 1 study testing Berobenatide in people with Overweight and/or Obesity and Healthy Participants, run by Pfizer at 1 site in United States.
Trial summary
This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy. The study involves multiple clinic visits at a study site over the length 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
- Overweight and/or Obesity, Healthy Participants
- What is being tested?
- Berobenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2026to 6 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants 18 years of age or older
- BMI of 27-45 kg/m2; and a total body weight >50 kg (110 lb)
Who cannot join
- Pregnant or breastfeeding women, or those planning pregnancy during the study
- History of other chronic disorders
- Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC
- Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility
- Acute GI symptoms at screening, Day -1, or prior to administration of study intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY
This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy.
The study involves multiple clinic visits at a study site over the length of the study.
- Conditions
- Overweight and/or Obesity, Healthy Participants
- Being tested
- Berobenatide
- Keywords
- overweight, obesity, healthy
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called PF-08653944
Solution for Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Dosing subcutaneous berobenatide Reference Delivery System 1 Receives: Drug: Berobenatide |
| Treatment 2 | Experimental | Dosing subcutaneous berobenatide Reference Delivery System 2 Receives: Drug: Berobenatide |
| Treatment 3 | Experimental | Dosing subcutaneous berobenatide Test Delivery System 1 Receives: Drug: Berobenatide |
| Treatment 4 | Experimental | Dosing subcutaneous berobenatide Test Delivery System 2 Receives: Drug: Berobenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide
Measured: Up to 85 days
PK: Maximum Observed Concentration (Cmax) of Berobenatide
Measured: Up to 85 days
Secondary outcomes (1)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 85 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start16 Oct 2026 (estimated)
- Primary completion6 Apr 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
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
- NCT07876531
- Sponsor's protocol ID
- C6491017
- Other IDs
- 2025-524803-65-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT07876531
- Acronym / sponsor ID
- C6491017
- Conditions
- Overweight and/or Obesity, Healthy Participants
- Keywords
- overweight, obesity, healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 15 Oct 2026 (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 single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy.
The study involves multiple clinic visits at a study site over the length of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: BerobenatideDosing subcutaneous berobenatide Reference Delivery System 1 |
| Treatment 2 | Experimental | Drug: BerobenatideDosing subcutaneous berobenatide Reference Delivery System 2 |
| Treatment 3 | Experimental | Drug: BerobenatideDosing subcutaneous berobenatide Test Delivery System 1 |
| Treatment 4 | Experimental | Drug: BerobenatideDosing subcutaneous berobenatide Test Delivery System 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants 18 years of age or older
- BMI of 27-45 kg/m2; and a total body weight >50 kg (110 lb)
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women, or those planning pregnancy during the study
- History of other chronic disorders
- Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC
- Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility
- Acute GI symptoms at screening, Day -1, or prior to administration of study intervention
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 |
|---|---|---|
| BerobenatideAlso: PF-08653944Solution for Injection | Drug | Treatment 1, Treatment 2, Treatment 3, Treatment 4 |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide
Time frame: Up to 85 days
PK: Maximum Observed Concentration (Cmax) of Berobenatide
Time frame: Up to 85 days
1 secondary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 85 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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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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.
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 Berobenatide in people with Overweight and/or Obesity and Healthy Participants, 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 5 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide (time frame: Up to 85 days). 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 15 Oct 2026.