NCT07575932

Brief Summary

This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
872

participants targeted

Target at P75+ for phase_2

Timeline
20mo left

Started May 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 11, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2028

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

OverweightObesityOverweight and/or ObesityOverweight or ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Keywords

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightObesityOverweightGLP-1RAAmylinDACRA

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in body weight

    Baseline (Week 0) to Week 48

Secondary Outcomes (8)

  • Percent change from baseline in body weight

    Baseline (Week 0) to Week 60

  • Change from baseline in body weight

    Baseline (Week 0) to Week 48 and Week 60

  • Percentage of participants who achieve ≥5% of body weight reduction from baseline

    Baseline (Week 0) to Week 48 and Week 60

  • Percentage of participants who achieve ≥10% of body weight reduction from baseline

    Baseline (Week 0) to Week 48 and Week 60

  • Percentage of participants who achieve ≥15% of body weight reduction from baseline

    Baseline (Week 0) to Week 48 and Week 60

  • +3 more secondary outcomes

Study Arms (3)

Cohort 1

EXPERIMENTAL

Participants receive subcutaneous injections of PF-08653945 or placebo.

Drug: PF-08653945Drug: Placebo

Cohort 2

EXPERIMENTAL

Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo.

Drug: PF-08653945Drug: PF-08653944Drug: Placebo

Cohort 3

EXPERIMENTAL

Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo.

Drug: PF-08653945Drug: PF-08653944Drug: Placebo

Interventions

PF-08653945DRUG

Subcutaneous Injection

Cohort 1Cohort 2Cohort 3
PF-08653944DRUG

Subcutaneous Injection

Cohort 2Cohort 3
PlaceboDRUG

Subcutaneous Injection

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants for this study include:
  • adults aged 18 years or older with
  • obesity (BMI of 30.0 kg/m2 to 50.0 kg/m2) or with
  • overweight (BMI of 27.0 kg/m2 to \<30.0 kg/m2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit.

You may not qualify if:

  • Participants who are not eligible include those with diabetes mellitus, a body weight change of \>5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ark Clinical Research

Fountain Valley, California, 92708, United States

Location

Paragon Rx Clinical

Garden Grove, California, 92840, United States

Location

Koch Family Medicine Clinical Research/Elite Research Network

Morton, Illinois, 61550, United States

Location

Related Links

MeSH Terms

Conditions

OverweightObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

May 11, 2026

Primary Completion (Estimated)

August 4, 2027

Study Completion (Estimated)

January 5, 2028

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

US(3)