A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity

NCT07876531
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Phase
Phase 1
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Recruitment status
Not yet recruiting
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Participants
144
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Lead sponsor
Pfizer
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Start date
2026-10-16
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Number of sites
1
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Summary
This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy. The study involves multiple clinic visits at a study site over the length of the study.
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Short title
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
clinicaltrials.gov
Official title
PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-04-06
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First posted
2026-10-15
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Registry last updated
2026-10-15
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Primary completion date
2027-04-06
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Start date
2026-10-16
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Participants
144
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Participant count basis
Estimated
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Planned participants
144
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07876531
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ClinicalTrials.gov ID
NCT07876531
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide

    Timeframe: Up to 85 days

  2. PK: Maximum Observed Concentration (Cmax) of Berobenatide

    Timeframe: Up to 85 days

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 85 Days

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

  • Participants 18 years of age or older
  • BMI of 27-45 kg/m2; and a total body weight >50 kg (110 lb)

Key Exclusion Criteria:

  • Pregnant or breastfeeding women, or those planning pregnancy during the study
  • History of other chronic disorders
  • Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC
  • Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility
  • Acute GI symptoms at screening, Day -1, or prior to administration of study intervention
Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical Trials, LLCAnaheim, United States
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-524803-65-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)