A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

9 Apr 2025 → 13 Jan 2026

Decision date (initial)

2025-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare the effect of multiple dose levels of PF-07976016 versus placebo on body weight in participants with obesity on a background of liraglutide.

Secondary objectives 1

1. To characterize the safety and tolerability of multiple dose levels of PF-07976016 administered to participants with obesity on a background of liraglutide.

Conditions and MedDRA coding

Obesity

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or non-pregnant, non-breastfeeding female, 18 (or the minimum age of consent in accordance with local regulations) to 74 years of age at Visit 1.
2. BMI ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as <5 kg change (per participant report) in the 12 weeks before Visit 1.
3. Eligible and willing to receive liraglutide (Saxenda®) according to prescribing information, including self-administration of daily injections.
4. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures including maintaining a dosing diary.

Exclusion criteria 11

1. Diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes.
2. Any condition possibly affecting drug absorption.
3. History of gastroparesis.
4. History of acute pancreatitis within 6 months before Visit 1 or any history of chronic pancreatitis.
5. Symptomatic gallbladder disease.
6. History, within 6 months before Visit 1, of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association (NYHA) Functional Class II-IV heart failure, or transient ischemic attack.
7. Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator’s judgement.
8. Known intolerance or hypersensitivity to liraglutide or other GLP-1R agonist(s), or any ingredients in the study interventions.
9. Presence, or history within the 2 years before Visit 1, of unstable major depressive disorder or any history of severe psychiatric disorder.
10. Use of any prohibited prior or concomitant medication(s), including GLP-1R agonists or other weight loss medication within 12 weeks before Visit 1.
11. Presence of specified abnormalities on clinical laboratory tests at Visit 1.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 1

1. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 2

Locations

2 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications