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C5541010 - A PHASE 2A, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF 07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513679-42-00
Acronym
C5541010
Enrollment
53
Registered
2025-03-13
Start date
2025-04-09
Completion date
2026-01-12
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Brief summary

Percent change from baseline (CFB) in body weight at Week 16.

Detailed description

Incidence of treatment-emergent Adverse Events (AEs) [AEs and Serious Adverse Events (SAEs)] o clinically significant abnormal laboratory, vital signs and electrocardiogram (ECG) parameters. o assessment of suicidal ideation and behavior (SIB) and depression symptoms as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire-8 (PHQ-8).

Interventions

DRUGSaxenda 6 mg/mL solution for injection in pre-filled pen
DRUGPlacebo for PF-07976016

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change from baseline (CFB) in body weight at Week 16.—

Secondary

MeasureTime frame
Incidence of treatment-emergent Adverse Events (AEs) [AEs and Serious Adverse Events (SAEs)] o clinically significant abnormal laboratory, vital signs and electrocardiogram (ECG) parameters. o assessment of suicidal ideation and behavior (SIB) and depression symptoms as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire-8 (PHQ-8).—

Countries

Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026