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SOLIS-1
Not yet recruitingPhase 2A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)
A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOSE RANGING, DOSE-FINDING, UMBRELLA STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08653945 AND PF-08653944, ALONE OR IN COMBINATION, IN ADULTS WITH OVERWEIGHT OR OBESITY (SOLIS-1)
Lead sponsor
Asset
MET097 / PF-08653944
Subcutaneous · GLP-1 agonist
Listed sites
3
Recruiting sites
—
Enrollment
872
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI 30-50
Primary endpoint
•Body weight
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Eligible participants for this study include:
Exclusion criteria
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.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
8 endpointsPercent change from baseline in body weight
Time frame:Baseline (Week 0) to Week 48
percent change from baseline, improvement
Percent change from baseline in body weight
Time frame:Baseline (Week 0) to Week 60
percent change from baseline, improvement
Change from baseline in body weight
Time frame:Baseline (Week 0) to Week 48 and Week 60
change from baseline, improvement
Percentage of participants who achieve ≥5% of body weight reduction from baseline
Time frame:Baseline (Week 0) to Week 48 and Week 60
threshold achievement, improvement
Percentage of participants who achieve ≥10% of body weight reduction from baseline
Time frame:Baseline (Week 0) to Week 48 and Week 60
threshold achievement, improvement
Percentage of participants who achieve ≥15% of body weight reduction from baseline
Time frame:Baseline (Week 0) to Week 48 and Week 60
threshold achievement, improvement
Percentage of participants who achieve ≥20% of body weight reduction from baseline
Time frame:Baseline (Week 0) to Week 48 and Week 60
threshold achievement, improvement
Percentage of participants who achieve ≥25% of body weight reduction from baseline
Time frame:Baseline (Week 0) to Week 48 and Week 60
threshold achievement, improvement
Safety / tolerability / PK
1 endpointNumber of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame:Up to Week 70
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.