ObesityPhase 3NCT07874633
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
A Phase 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 2 sites in China.
Trial summary
Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Berobenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 2 sitesChina
- Study dates
- 15 Oct 2026to 15 Aug 2028
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age.
- BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
- At least one prior unsuccessful dietary weight-loss attempt.
Who cannot join
- Significant recent weight change (>5% within 3 months).
- Type 1 diabetes mellitus.
- History of pancreatitis.
- Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).
- Recent bariatric surgery or obesity procedures.
- Pregnancy or breastfeeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
The Second People's Hospital of Hefei
Hefei, Anhui, 230011
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF 08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY
Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.
About 432 adults will take part in this study. This study is seeking adults who
Read more
- are obese
- are overweight with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.
Participants will be randomly assigned to receive either berobenatide or placebo. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.
Researchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.
Participants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.
- Conditions
- Obesity, Overweight
- Being tested
- Berobenatide, Placebo
- Keywords
- Obesity, Overweight, Weight Management, Weight Reduction, Body Weight, Chronic Weight Management, Adults With Obesity, Adults With Overweight, Metabolic Diseases
- Medical subject headings
- Obesity, Overweight, Weight Loss, Body Weight, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called PF-08653944
By Subcutaneous Injection
PlaceboOther
By Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive matching placebo by Subcutaneous Injection. Receives: Other: Placebo |
| Treatment Arm 1 | Experimental | Participants will receive Berobenatide by Subcutaneous Injection. Receives: Drug: Berobenatide |
| Treatment Arm 2 | Experimental | Participants will receive Berobenatide by Subcutaneous Injection. Receives: Drug: Berobenatide |
| Treatment Arm 3 | Experimental | Participants will receive Berobenatide by Subcutaneous Injection. Receives: Drug: Berobenatide |
| Treatment Arm 4 | Experimental | Participants will receive Berobenatide by Subcutaneous Injection. Receives: Drug: Berobenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight
Measured: Baseline, Week 48
Secondary outcomes (39)
Percent change from baseline in body weight in participants without T2D
Measured: Baseline, Week 48
Change from baseline in body weight
Measured: Baseline, Week 48
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Measured: Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Measured: Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Measured: Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Measured: Baseline, Week 48
Change from baseline in waist circumference
Measured: Baseline, Week 48
Change from baseline in Fasting triglycerides
Measured: Baseline, Week 48
Change from baseline in Non-high-density lipoprotein-cholesterol
Measured: Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 48
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
Measured: Baseline, Week 48
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Measured: Baseline, Week 48
Change from Baseline in Body mass index (BMI)
Measured: Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 48
Change from baseline in Total Cholesterol
Measured: Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from Baseline in HbA1c
Measured: Baseline, Week 48
Change from Baseline in Fasting plasma glucose
Measured: Baseline, Week 48
Change from Baseline in Fasting insulin
Measured: Baseline, Week 48
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline, Week 48
Change from baseline in Interleukin (IL)-6
Measured: Baseline, Week 48
Change from baseline in IL-1 beta
Measured: Baseline, Week 48
Change from Baseline in HbA1c in participants with T2D
Measured: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Measured: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <6.5%
Measured: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <5.7%
Measured: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT total score
Measured: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
Measured: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Measured: Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
Measured: Baseline, Week 48
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
Measured: Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Measured: Baseline, Week 48
Incidence proportion of Treatment-emergent adverse event (TEAE)
Measured: Up to Week 55
Incidence proportion of Serious adverse event (SAE)
Measured: Up to Week 55
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
Measured: Up to Week 55
Incidence proportion of Adverse events of special interest (AESIs)
Measured: Up to Week 55
Incidence proportion of Clinical laboratory abnormalities
Measured: Up to Week 55
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 start15 Oct 2026 (estimated)
- Primary completion6 Jun 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 432 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
- NCT07874633
- Sponsor's protocol ID
- C6491029
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF 08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY
- ClinicalTrials.gov ID
- NCT07874633
- Acronym / sponsor ID
- C6491029
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Weight Management, Weight Reduction, Body Weight, Chronic Weight Management, Adults With Obesity, Adults With Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 6 Jun 2028 (estimated)
- Study completion
- 15 Aug 2028 (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.
Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.
About 432 adults will take part in this study. This study is seeking adults who
- are obese
- are overweight with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.
Participants will be randomly assigned to receive either berobenatide or placebo. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.
Researchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.
Participants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive matching placebo by Subcutaneous Injection. |
| Treatment Arm 1 | Experimental | Drug: BerobenatideParticipants will receive Berobenatide by Subcutaneous Injection. |
| Treatment Arm 2 | Experimental | Drug: BerobenatideParticipants will receive Berobenatide by Subcutaneous Injection. |
| Treatment Arm 3 | Experimental | Drug: BerobenatideParticipants will receive Berobenatide by Subcutaneous Injection. |
| Treatment Arm 4 | Experimental | Drug: BerobenatideParticipants will receive Berobenatide by Subcutaneous Injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years of age.
- BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
- At least one prior unsuccessful dietary weight-loss attempt.
Key exclusion criteria (6 listed)
- Significant recent weight change (>5% within 3 months).
- Type 1 diabetes mellitus.
- History of pancreatitis.
- Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).
- Recent bariatric surgery or obesity procedures.
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-08653944By Subcutaneous Injection | Drug | Treatment Arm 1, Treatment Arm 2, Treatment Arm 3, Treatment Arm 4 |
| PlaceboBy Subcutaneous Injection | Other | Placebo |
Primary outcome
Percent change from baseline in body weight
Time frame: Baseline, Week 48
39 secondary outcomes
Percent change from baseline in body weight in participants without T2D
Time frame: Baseline, Week 48
Change from baseline in body weight
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Time frame: Baseline, Week 48
Change from baseline in waist circumference
Time frame: Baseline, Week 48
Change from baseline in Fasting triglycerides
Time frame: Baseline, Week 48
Change from baseline in Non-high-density lipoprotein-cholesterol
Time frame: Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 48
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
Time frame: Baseline, Week 48
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Time frame: Baseline, Week 48
Change from Baseline in Body mass index (BMI)
Time frame: Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 48
Change from baseline in Total Cholesterol
Time frame: Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from Baseline in HbA1c
Time frame: Baseline, Week 48
Change from Baseline in Fasting plasma glucose
Time frame: Baseline, Week 48
Change from Baseline in Fasting insulin
Time frame: Baseline, Week 48
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Week 48
Change from baseline in Interleukin (IL)-6
Time frame: Baseline, Week 48
Change from baseline in IL-1 beta
Time frame: Baseline, Week 48
Change from Baseline in HbA1c in participants with T2D
Time frame: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Time frame: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <6.5%
Time frame: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <5.7%
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT total score
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Time frame: Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
Time frame: Baseline, Week 48
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
Time frame: Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: Baseline, Week 48
Incidence proportion of Treatment-emergent adverse event (TEAE)
Time frame: Up to Week 55
Incidence proportion of Serious adverse event (SAE)
Time frame: Up to Week 55
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
Time frame: Up to Week 55
Incidence proportion of Adverse events of special interest (AESIs)
Time frame: Up to Week 55
Incidence proportion of Clinical laboratory abnormalities
Time frame: Up to Week 55
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: Yes. 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 2 sites in China.
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 6 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 2 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent change from baseline in body weight (time frame: Baseline, Week 48). 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.