ClinicalTrials.gg
RecruitingNCT07845500Updated Nov 5, 2026

A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity

A Phase 3 interventional study of Semaglutide and Berobenatide in Obesity, Overweight and/or Obesity and Overweight, sponsored by Pfizer. Recruiting at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 5, 2026Now RecruitingFirst site in Australia+4 moreGo to Updates ↓

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Phase
Phase 3
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 21 studies testing berobenatide in Obesity — 11 open to participants now, 15 under way, 12 of them phase 3. berobenatide · Obesity.

Planned enrollment
6th of 21
660 · median 258
Started
2026
with 14 others
Phase 3
12 of 21
10 open now
Primary completion
2028-02
later than 5 of 14 live
Registered
15th of 21
by date
Lead sponsor
20 of 21
Pfizer

Among the 21 studies testing berobenatide in Obesity, this one is the 6th largest by planned enrollment, is one of 15 that started in 2026, is one of 12 in phase 3, reaches primary completion later than 5 of the 14 other live ones, and was the 15th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

11 of the 21 studies testing berobenatide in Obesity are open now, in 12 countries. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

About berobenatide

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies testing berobenatide in Obesity, or all of them as a file.
02

Study summary

The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.

Participants will be in the study for about 11 months.

03

Conditions studied

  • Obesity
  • Overweight and/or Obesity
  • Overweight
  • Treatment Of Obesity

Keywords

  • nutrition disorder
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥18 years.
  • Currently taking semaglutide or tirzepatide for obesity management.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of any form of diabetes.
  • History of acute or chronic pancreatitis.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
660 participants (estimated)

Study arms

  • Active comparator
    Active Comparator

    Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.

    Drug: Semaglutide · Drug: Tirzepatide

  • Experimental
    Experimental

    Participants will receive Berobenatide by Subcutaneous Injection.

    Drug: Berobenatide

Interventions

  • Participants will receive Semaglutide administered subcutaneously.

  • Participants will receive berobenatide solution for injection as subcutaneous injection.

    Also known as: MET097, PF-08653944

  • Participants will receive Tirzepatide administered subcutaneously.

06

What researchers measure

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline, Week 32

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: Baseline, Week 32

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline, Week 32

  3. Number of Participants with Serious adverse events (SAEs)

    Time frame: Baseline, Week 32

  4. Number of Participants with adverse events leading to discontinuation

    Time frame: Baseline, Week 32

  5. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Baseline, Week 32

  6. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Baseline, Week 32

07

Study locations

18 of 26 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · www.pfizer.com

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2028, 16 months after the start.

Of 199 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 16 months is below that.

Counting every sponsor, half of 262 studies reached it within 24 months; a quarter within 18 and three quarters within 34.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Oct 15, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2026
First posted
Sep 29, 2026
StartActual
Sep 30, 2026was Oct 2026
Primary completionEst.
Feb 16, 2028
CompletionEst.
Feb 16, 2028
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 15, 2026
Sites
18 sites added — first site in Australia. 14 sites changed recruiting status (14 now recruiting)
Show 14 sites
  • University of Alabama at Birmingham · Birmingham, United Statesno status→Recruiting
  • Suncoast Clinical Research · New Port Richey, United Statesno status→Recruiting
  • Monroe Biomedical Research · Louisville, United Statesno status→Recruiting
  • Aa Mrc Llc · Flint, United Statesno status→Recruiting
  • Clinical Research Professionals · Chesterfield, United Statesno status→Recruiting
  • Mercury Street Medical Group, PLLC · Butte, United Statesno status→Recruiting
  • Accellacare - Wilmington · Wilmington, United Statesno status→Recruiting
  • Velocity Clinical Research, Mt. Auburn · Cincinnati, United Statesno status→Recruiting
  • Velocity Clinical Research - Los Angeles · Los Angeles, United StatesNot yet recruiting→Recruiting
  • Southern California Clinical Research · Santa Ana, United StatesNot yet recruiting→Recruiting
  • Diablo Clinical Research, LLC dba Flourish Research · Walnut Creek, United StatesNot yet recruiting→Recruiting
  • Jacksonville Center for Clinical Research · Jacksonville, United StatesNot yet recruiting→Recruiting
  • Oviedo Medical Research · Oviedo, United StatesNot yet recruiting→Recruiting
  • Tribe Clinical Research, LLC · Greenville, United StatesNot yet recruiting→Recruiting
Show 18 added (16 United States, 2 Australia)
  • Velocity Clinical Research - Los Angeles · Los Angeles, United States
  • Southern California Clinical Research · Santa Ana, United States
  • Diablo Clinical Research, LLC dba Flourish Research · Walnut Creek, United States
  • Jacksonville Center for Clinical Research · Jacksonville, United States
  • Oviedo Medical Research · Oviedo, United States
  • SKY Integrative Medical Center/SKYCRNG · Ridgeland, United States
  • Monroe Biomedical Research · Monroe, United States
  • Tribe Clinical Research, LLC · Greenville, United States
  • San Fernando Valley Health Institute · Canoga Park, United States
  • Headlands Research Sacramento · Sacramento, United States
  • Southern California Retina Specialists · West Hills, United States
  • Westside Center for Clinical Research · Jacksonville, United States
  • Center for Diabetes, Obesity and Metabolism Inc · Pembroke Pines, United States
  • MediSphere Medical Research Center, LLC · Evansville, United States
  • Medication Management, LLC · Greensboro, United States
  • York Clinical Research, LLC · Norfolk, United States
  • Emeritus Research Sydney · Botany, Australia
  • Emeritus Research Camberwell · Camberwell, Australia
across 2 updates, Oct 15, 2026 – Nov 5, 2026
Start date
Oct 1, 2026→Sep 30, 2026 (actual)
Oct 15, 2026
Registered
First appeared on the registry
Sep 29, 2026
Show all 3 updates
  1. Nov 5, 2026
    10 sites added — first site in Australia. 9 sites changed recruiting status (9 now recruiting)
    Show 9 sites
    • Velocity Clinical Research - Los Angeles · Los Angeles, United StatesNot yet recruiting→Recruiting
    • Southern California Clinical Research · Santa Ana, United StatesNot yet recruiting→Recruiting
    • Diablo Clinical Research, LLC dba Flourish Research · Walnut Creek, United StatesNot yet recruiting→Recruiting
    • Jacksonville Center for Clinical Research · Jacksonville, United StatesNot yet recruiting→Recruiting
    • Suncoast Clinical Research · New Port Richey, United StatesNot yet recruiting→Recruiting
    • Oviedo Medical Research · Oviedo, United StatesNot yet recruiting→Recruiting
    • Aa Mrc Llc · Flint, United StatesNot yet recruiting→Recruiting
    • Accellacare - Wilmington · Wilmington, United StatesNot yet recruiting→Recruiting
    • Tribe Clinical Research, LLC · Greenville, United StatesNot yet recruiting→Recruiting
    Show 10 added (8 United States, 2 Australia)
    • San Fernando Valley Health Institute · Canoga Park, United States
    • Headlands Research Sacramento · Sacramento, United States
    • Southern California Retina Specialists · West Hills, United States
    • Westside Center for Clinical Research · Jacksonville, United States
    • Center for Diabetes, Obesity and Metabolism Inc · Pembroke Pines, United States
    • MediSphere Medical Research Center, LLC · Evansville, United States
    • Medication Management, LLC · Greensboro, United States
    • York Clinical Research, LLC · Norfolk, United States
    • Emeritus Research Sydney · Botany, Australia
    • Emeritus Research Camberwell · Camberwell, Australia
    + 1 other change: verification date
  2. Oct 15, 2026
    Not yet recruiting→Recruiting
    8 sites added. 8 sites changed recruiting status (5 now recruiting, 3 now not yet recruiting)
    Show 8 sites
    • University of Alabama at Birmingham · Birmingham, United Statesno status→Recruiting
    • Suncoast Clinical Research · New Port Richey, United Statesno status→Not yet recruiting
    • Monroe Biomedical Research · Louisville, United Statesno status→Recruiting
    • Aa Mrc Llc · Flint, United Statesno status→Not yet recruiting
    • Clinical Research Professionals · Chesterfield, United Statesno status→Recruiting
    • Mercury Street Medical Group, PLLC · Butte, United Statesno status→Recruiting
    • Accellacare - Wilmington · Wilmington, United Statesno status→Not yet recruiting
    • Velocity Clinical Research, Mt. Auburn · Cincinnati, United Statesno status→Recruiting
    Show 8 added (8 United States)
    • Velocity Clinical Research - Los Angeles · Los Angeles, United States
    • Southern California Clinical Research · Santa Ana, United States
    • Diablo Clinical Research, LLC dba Flourish Research · Walnut Creek, United States
    • Jacksonville Center for Clinical Research · Jacksonville, United States
    • Oviedo Medical Research · Oviedo, United States
    • SKY Integrative Medical Center/SKYCRNG · Ridgeland, United States
    • Monroe Biomedical Research · Monroe, United States
    • Tribe Clinical Research, LLC · Greenville, United States
    Start date Oct 1, 2026→Sep 30, 2026 (now actual)
    + 1 other change: verification date
  3. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07845500
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 30, 2026
Primary completion
Feb 16, 2028 (estimated)
Completion
Feb 16, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Berobenatide

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