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| ID | Type | Description | Link |
|---|---|---|---|
| VESPER-6 | Other Identifier | Alias Study Number | |
| 2026-525318-75-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.
About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.
People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Experimental | Participants will receive PF-08653944 by Subcutaneous Injection. |
|
| Treatment Arm 2 | Experimental | Participants will receive PF-08653944 by Subcutaneous Injection. |
|
| Treatment Arm 3 | Experimental | Participants will receive PF-08653944 by Subcutaneous Injection. |
|
| Treatment Arm 4 | Experimental | Participants will receive PF-08653944 by Subcutaneous Injection. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo by Subcutaneous Injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08653944 | Drug | By Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in body weight | Baseline, Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight | Baseline, Week 72 | |
| Change from baseline in waist circumference | Baseline, Week 72 | |
| Percentage of Participants achieving ≥5% of body weight reduction from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImmuniMet, LLC | Recruiting | Modesto | California | 95350 | United States | |
| ClearVue Eye Care |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| Placebo | Other | By Subcutaneous Injection |
|
| Baseline, Week 72 |
| Percentage of Participants achieving ≥10% of body weight reduction from baseline | Baseline, Week 72 |
| Percentage of Participants achieving ≥15% of body weight reduction from baseline | Baseline, Week 72 |
| Percentage of Participants achieving ≥20% of body weight reduction from baseline | Baseline, Week 72 |
| Percentage of Participants with a waist-to-height ratio of <0.53 | Baseline, Week 72 |
| Percent change from baseline in body weight in participants with type 2 diabetes | Baseline, Week 72 |
| Change from baseline in Systolic Blood Pressure (SBP) | Baseline, Week 72 |
| Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score | Baseline, Week 72 |
| Percentage of Participants achieving ≥25% of body weight reduction from baseline | Baseline, Week 72 |
| Change from baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 72 |
| Change from Baseline in Fasting Glucose | Basline, Week 72 |
| Change from Baseline in Fasting insulin | Baseline, Week 72 |
| Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S) | Baseline, Week 72 |
| Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B) | Baseline, Week 72 |
| Change from Baseline in HbA1c | Baseline, Week 72 |
| Change from baseline in Fasting Total Cholesterol | Baseline, Week 72 |
| Change from baseline in Fasting Low-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in Fasting Very low-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in Fasting Non-High-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in Fasting High-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in Fasting triglycerides | Baseline, Week 72 |
| Change from baseline in high-sensitivity C-reactive protein | Baseline, Week 72 |
| Change from baseline in interleukin-6 | Baseline, Week 72 |
| Change from baseline in interleukin-1 beta | Baseline, Week 72 |
| Change from baseline in IWQoL-Lite-CT total score | Baseline, Week 72 |
| Change from baseline in IWQoL-Lite-CT Physical composite score | Baseline, Week 72 |
| Change from baseline in IWQoL-Lite-CT Psychosocial composite score | Baseline, Week 72 |
| Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales | Baseline, Week 72 |
| Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales | Baseline, Week 72 |
| Change from Baseline in Food Noise Questionnaire (FNQ) total score | Baseline, Week 72 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline, Week 72 |
| Number of Participants with Serious adverse events (SAEs) | Baseline, Week 72 |
| Number of Participants with adverse avents leading to discontinuation | Baseline, Week 72 |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Baseline, Week 72 |
| Recruiting |
| Roseville |
| California |
| 95661 |
| United States |
| Clinical Trials Research | Recruiting | Sacramento | California | 95821 | United States |
| University Clinical Investigators, Inc. | Not yet recruiting | Tustin | California | 92780 | United States |
| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
| Nature Coast Clinical Research | Recruiting | Crystal River | Florida | 34429 | United States |
| West Coast Eye Institute | Recruiting | Lecanto | Florida | 34461 | United States |
| South Broward Research | Not yet recruiting | Miramar | Florida | 33027 | United States |
| Suncoast Clinical Research, Inc. | Recruiting | New Port Richey | Florida | 34652 | United States |
| West Coast Medical Associates | Recruiting | New Port Richey | Florida | 34652 | United States |
| MediSphere Medical Research Center, LLC | Recruiting | Evansville | Indiana | 47714 | United States |
| Monroe Biomedical Research | Not yet recruiting | Louisville | Kentucky | 40213 | United States |
| Aa Mrc Llc | Not yet recruiting | Flint | Michigan | 48504 | United States |
| Albuquerque Clinical Trials, Inc. | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Rochester Clinical Research, LLC | Recruiting | Rochester | New York | 14609 | United States |
| Medication Management LLC | Recruiting | Greensboro | North Carolina | 27405 | United States |
| Midwest Eye Center | Recruiting | Cincinnati | Ohio | 45202 | United States |
| Velocity Clinical Research, Mt. Auburn | Recruiting | Cincinnati | Ohio | 45219 | United States |
| VIP Trials | Recruiting | San Antonio | Texas | 78230 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| D001835 | Body Weight |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
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