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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

ConditionsObesityOverweight and/or ObesityOverweightTreatment Of Obesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years.

Currently taking semaglutide or tirzepatide for obesity management.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide

    Drug

    Participants will receive Semaglutide administered subcutaneously.

  • Tirzepatide

    Drug

    Participants will receive Tirzepatide administered subcutaneously.

  • Berobenatide

    Drug

    Participants will receive berobenatide solution for injection as subcutaneous injection.

Treatment groups

660 Participants
are divided into 2 treatment groups
Group A: Active ComparatorActive comparator 2 interventions
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: