A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PF-08653945, PF-08653944, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight, Obesity, Overweight and/or Obesity, Overweight or Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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).
Interventions
- Drug PF-08653945
Subcutaneous Injection - Drug PF-08653944
Subcutaneous Injection - Drug Placebo
Subcutaneous Injection
Primary outcome measures
- Percent change from baseline in body weight [Time frame: Baseline (Week 0) to Week 48]
Secondary outcome measures (8)
- Percent change from baseline in body weight [Time frame: Baseline (Week 0) to Week 60]
- Change from baseline in body weight [Time frame: Baseline (Week 0) to Week 48 and Week 60]
- Percentage of participants who achieve ≥5% of body weight reduction from baseline [Time frame: Baseline (Week 0) to Week 48 and Week 60]
- Percentage of participants who achieve ≥10% of body weight reduction from baseline [Time frame: Baseline (Week 0) to Week 48 and Week 60]
- Percentage of participants who achieve ≥15% of body weight reduction from baseline [Time frame: Baseline (Week 0) to Week 48 and Week 60]
- Percentage of participants who achieve ≥20% of body weight reduction from baseline [Time frame: Baseline (Week 0) to Week 48 and Week 60]
- Percentage of participants who achieve ≥25% of body weight reduction from baseline [Time frame: Baseline (Week 0) to Week 48 and Week 60]
- Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [Time frame: Up to Week 70]
Eligibility criteria
Inclusion criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 55 centers
- Arizona Clinical Trials-Chandler — Chandler
- Clinical Research Institute of Arizona — Sun City West
- Arizona Clinical Trials (ACT) - Tucson — Tucson
- San Fernando Valley Health Institute — Canoga Park
- Ark Clinical Research — Fountain Valley
- Paragon Rx Clinical — Garden Grove
- Torrance Clinical Research Institute, Inc. — Lomita
- Ark Clinical Research — Long Beach
- … and 47 more centers
Canada · 10 centers
- Viable Clinical Research Corporation — Bridgewater
- Aggarwal and Associates Limited — Brampton
- Centricity Research Etobicoke Endocrinology — Etobicoke
- Milestone Research Inc. — London
- Bluewater Clinical Research Group Inc. — Sarnia
- Dr. Anil K. Gupta Medicine Professional Corporation — Toronto
- Centricity Research Toronto Manna Multispecialty — Toronto
- Ecogene-21 — Chicoutimi
- … and 2 more centers
Identifiers
NCT: NCT07575932 · C6511002 · SOLIS-1