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NCT Number: NCT07575932

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

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).

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight and/or Obesity Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Viable Clinical Research Corporation, Bridgewater, Nova Scotia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-08653945

Drug

Subcutaneous Injection

PF-08653944

Drug

Subcutaneous Injection

Placebo

Drug

Subcutaneous Injection

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

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

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

  6. Percentage of participants who achieve ≥20% of body weight reduction from baseline

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

  7. Percentage of participants who achieve ≥25% of body weight reduction from baseline

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

  8. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Up to Week 70

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Acronym: SOLIS-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 8, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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