ObesityPhase 2VESPER-1NCT06712836
A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight
A Phase 2 study testing MET097 in people with Obesity and Overweight or Obesity, run by Pfizer at 2 sites in United States.
Trial summary
This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight or Obesity
- What is being tested?
- MET097
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2024to 30 Apr 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) at Screening of:
- BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below)
- BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the following weight-related co-morbidities:
- Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
- Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for women at Screening
- Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening
Who cannot join
- Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose >125 mg/dL.
- Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Any lifetime history of a suicide attempt.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Research Centers of America
Hollywood, Florida, 92801
About this study
Official title: A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of 28 Weeks to Investigate the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight Followed by a 32-Week Extension (VESPER-1)
This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index [BMI] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.
- Conditions
- Obesity, Overweight or Obesity
- Being tested
- MET097, Placebo
- Keywords
- Overweight, GLP-1
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET097Drug
MET097 is an ultra-long-acting, fully-biased analog of human GLP-1.
PlaceboDrug
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.
| Study group | Role | What they receive |
|---|---|---|
| MET097 Active | Experimental | MET097 will be administered at four different dose levels subcutaneously once-weekly without titration. The extension phase includes dosing regimens that are less frequent than weekly. Receives: Drug: MET097 |
| Placebo | Placebo comparator | Sterile 0.9% (w/v) saline will be used as placebo treatment during the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 28: Part A
Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance. The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.
Measured: Baseline (last non-missing measurement prior to the first dose), Week 28
Secondary outcomes (25)
Percent Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169: Part A
Analysis was performed using MMRM with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance excluding weight measurements after protocol specified intercurrent ICEs.
Measured: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A
Measured: Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
Measured: Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
Measured: Baseline, Week 28
Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Measured: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Change From Baseline in Body Mass Index (BMI) at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
BMI was derived from body weight in kilograms (kg) and height in meters (m), and it was calculated as weight divided by height^2.
Measured: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Change From Baseline in Waist Circumference at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Measured: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea.
Measured: From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Related Gastrointestinal AECIs: Part A
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea. Treatment related gastrointestinal AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator.
Measured: From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea. Treatment related GI AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator. Severity was assessed as mild: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; moderate: minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living or life-threatening consequences, urgent intervention indicated or death related to an AE.
Measured: From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment. A TEAE was defined as any AE which on or after exposure to study treatment. Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.
Measured: Up to Week 37
Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A
An AE was defined as any untoward medical occurrence in participant administered an investigational product and which does not necessarily have causal relationship with treatment. A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose. Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator. Severity: mild: asymptomatic/ mild symptoms, clinical/ diagnostic observations only, intervention not indicated; moderate: minimal, local/ non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization/ prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living/ life-threatening consequences, urgent intervention indicated/ death related to an AE.
Measured: Up to Week 37
Number of Participants With Abnormal Clinically Significant Physical Examination: Part A
The physical examination included examination of the following body systems (at minimum): head and neck (including complete thyroid exam), cardiovascular, respiratory, gastrointestinal, brief neurological, and general appearance. Clinical significance will be judged by investigator.
Measured: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: Part A
Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes. Clinical significance will be judged by investigator.
Measured: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Potential Clinically Significant Laboratory Values: Part A
Laboratory parameters assessed included alanine aminotransferase (ALT) (units per liter [U/L]): greater than (>) 1*upper limit of normal (ULN), >3*ULN and >5*ULN; alkaline phosphatase (ALP) (U/L): >2*ULN; amylase (U/L): >1*ULN and >3*ULN; aspartate aminotransferase (AST): >1*ULN, >3*ULN and >5*ULN; estimated glomerular filtration rate (eGFR) (Ckd-Epi [chronic kidney disease epidemiology collaboration]) (milliliter per minute per 1.73m^2): less than (<) 60 mL/min/1.73m^2, 60-90 mL/min/1.73m^2 and >90 mL/min/1.73m^2; Lipase: >1*ULN and >3*ULN; neutrophils: <1.5, <0.5, 0.5 to <1, 1 to <1.5 and total bilirubin (milligrams per deciliter): >2* upper limit of normal (ULN). Potential clinical significance was judged by investigator.
Measured: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Categories: Part A
The C-SSRS is a questionnaire designed for the assessment of suicidal ideation and behavior in adolescents and adults. C-SSRS were evaluated through category 1 to 10. Suicidal ideation score was defined as the maximum suicidal ideation category (i.e., category 1-5), with 0 assigned if no ideation was present. Suicidal ideation, defined as 'Yes' if 'Yes' was present in any of category 1-5 and suicidal behavior, defined as 'Yes' if 'Yes' was present in any of category 6-10 and suicidal ideation or behavior, defined as 'Yes' if 'Yes' was present in any of Category 1-10.
Measured: From Day 1 of dosing up to post treatment follow up for Part A
Patient Health Questionnaire-9 (PHQ-9) Total Score: Part A
The PHQ-9 is a questionnaire designed to monitor and measure the severity of depression in participants. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "0=not at all", "several days", "more than half the days" to "nearly every day". The total score ranges from 0 to 27 by adding score for each question (total points) where: Score 1-4: minimal depression; Score 5-9: Mild depression; Score 10-14: moderate depression; Score 15-19 moderately severe depression; Score 20-27: Severe depression. Higher score indicates greater severity of depression.
Measured: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Anti Drug Antibodies (ADAs): Part A
Number of participants with baseline, positive and negative ADAs are reported in this outcome measure.
Measured: From Day 1 of dosing up to post treatment follow up for Part A
Minimum Observed Concentration (Cmin) of Berobenatide: Part A
Measured: From pre-dose on Day 1 up to 168 hours post-dose
Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of Berobenatide: Part A
AUCtau was area under the concentration versus time curve during the dosing interval (tau), where, tau=168 hours.
Measured: From pre-dose on Day 1 up to 168 hours post-dose
Maximum Observed Concentration (Cmax) of Berobenatide: Part A
Cmax was observed directly from data.
Measured: From pre-dose on Day 1 up to 168 hours post-dose
Time to Maximum Concentration (Tmax) of Berobenatide: Part A
Measured: From pre-dose on Day 1 up to 168 hours post-dose
Plasma Concentration of Berobenatide: Part A
Measured: From pre-dose on Day 1 up to 168 hours post-dose
Percent Change From Baseline in Body Weight: Part B
Measured: Baseline (last available measurement prior to first dose received in Part A), End of study
Number of Participants With TEAEs: Part B
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment. A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose.
Measured: From Day 1 of dosing in Part B up to 28 days after last dose for Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start9 Oct 2024
- Primary completion3 Jul 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 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
- NCT06712836
- Sponsor's protocol ID
- VESPER-1 (MET097-24-201)
- Other IDs
- C6491004
- Acronym
- VESPER-1
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2024
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of 28 Weeks to Investigate the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight Followed by a 32-Week Extension (VESPER-1)
- ClinicalTrials.gov ID
- NCT06712836
- Acronym / sponsor ID
- VESPER-1 / VESPER-1 (MET097-24-201)
- Conditions
- Obesity, Overweight or Obesity
- Keywords
- Overweight, GLP-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels. Participants who have completed the first 28 weeks may participate in an exploratory extension study.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of four different dose levels of MET097 vs. placebo for body weight loss in adult participants with obesity or overweight (body mass index [BMI] 27 to 50 kg/m2, aged 18 to 70), after 28 weeks with once weekly dosing. Participants who have completed the first 28 weeks may participate in an exploratory extension study that includes less frequent dosing regimens. After the dosing period, there is an additional post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MET097 Active | Experimental | Drug: MET097MET097 will be administered at four different dose levels subcutaneously once-weekly without titration. The extension phase includes dosing regimens that are less frequent than weekly. |
| Placebo | Placebo comparator | Drug: PlaceboSterile 0.9% (w/v) saline will be used as placebo treatment during the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) at Screening of:
- Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening
Key exclusion criteria (6 listed)
- Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose >125 mg/dL.
- Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
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 |
|---|---|---|
| MET097MET097 is an ultra-long-acting, fully-biased analog of human GLP-1. | Drug | MET097 Active |
| PlaceboSterile 0.9% (w/v) saline will be used as placebo treatment during the study. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight at Week 28: Part A
Time frame: Baseline (last non-missing measurement prior to the first dose), Week 28
Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance. The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.
25 secondary outcomes
Percent Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169: Part A
Time frame: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A
Time frame: Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
Time frame: Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
Time frame: Baseline, Week 28
Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Time frame: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Change From Baseline in Body Mass Index (BMI) at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Time frame: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Change From Baseline in Waist Circumference at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Time frame: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A
Time frame: From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Related Gastrointestinal AECIs: Part A
Time frame: From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A
Time frame: From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A
Time frame: Up to Week 37
Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A
Time frame: Up to Week 37
Number of Participants With Abnormal Clinically Significant Physical Examination: Part A
Time frame: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: Part A
Time frame: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Potential Clinically Significant Laboratory Values: Part A
Time frame: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Categories: Part A
Time frame: From Day 1 of dosing up to post treatment follow up for Part A
Patient Health Questionnaire-9 (PHQ-9) Total Score: Part A
Time frame: From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Anti Drug Antibodies (ADAs): Part A
Time frame: From Day 1 of dosing up to post treatment follow up for Part A
Minimum Observed Concentration (Cmin) of Berobenatide: Part A
Time frame: From pre-dose on Day 1 up to 168 hours post-dose
Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of Berobenatide: Part A
Time frame: From pre-dose on Day 1 up to 168 hours post-dose
Maximum Observed Concentration (Cmax) of Berobenatide: Part A
Time frame: From pre-dose on Day 1 up to 168 hours post-dose
Time to Maximum Concentration (Tmax) of Berobenatide: Part A
Time frame: From pre-dose on Day 1 up to 168 hours post-dose
Plasma Concentration of Berobenatide: Part A
Time frame: From pre-dose on Day 1 up to 168 hours post-dose
Percent Change From Baseline in Body Weight: Part B
Time frame: Baseline (last available measurement prior to first dose received in Part A), End of study
Number of Participants With TEAEs: Part B
Time frame: From Day 1 of dosing in Part B up to 28 days after last dose for Part B
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 2 study testing MET097 in people with Obesity and Overweight or Obesity, run by Pfizer at 2 sites 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 6 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: finished, as of the sponsor's last update on 28 Aug 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Body Weight at Week 28: Part A (time frame: Baseline (last non-missing measurement prior to the first dose), Week 28). 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 28 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.