Health TrialsbyHealthPanel

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)

ConditionsOverweightObesityOverweight and/or ObesityOverweight or ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • PF-08653945

    Drug

    Subcutaneous Injection

  • PF-08653944

    Drug

    Subcutaneous Injection

  • Placebo

    Drug

    Subcutaneous Injection

Treatment groups

872 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 3 interventions
Group C: Cohort 3Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percent change from baseline in body weight

Time frame
Baseline (Week 0) to Week 48

Secondary outcomes

1

Percent change from baseline in body weight

Time frame
Baseline (Week 0) to Week 60
2

Change from baseline in body weight

Time frame
Baseline (Week 0) to Week 48 and Week 60
3

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

Time frame
Baseline (Week 0) to Week 48 and Week 60
4

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

Time frame
Baseline (Week 0) to Week 48 and Week 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
Apply now