ClinicalTrials.gg
Active, not recruitingNCT07575932SOLIS-1Updated Nov 5, 2026

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity

A Phase 2 interventional study of PF-08653945 and PF-08653944 in Overweight, Obesity and Overweight and/or Obesity, sponsored by Pfizer. Active, not recruiting at 63 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
940
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Overweight
  • Obesity
  • Overweight and/or Obesity
  • Overweight or Obesity
  • Overnutrition
  • Nutrition Disorders
  • Nutritional and Metabolic Diseases
  • Body Weight

Keywords

  • Overnutrition
  • Nutrition Disorders
  • Nutritional and Metabolic Diseases
  • Body Weight
  • Obesity
  • Overweight
  • GLP-1RA
  • Amylin
  • DACRA
03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 940 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Eligible participants for this study include:

  • adults aged 18 years or older with
  • obesity ( 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

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 requirements or are pregnant or lactating.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
940 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Participants receive subcutaneous injections of PF-08653945 or placebo.

    Drug: PF-08653945 · Drug: Placebo

  • Experimental
    Cohort 2

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

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

  • Experimental
    Cohort 3

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

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

Interventions

  • DrugPF-08653945

    Subcutaneous Injection

  • Subcutaneous Injection

  • DrugPlacebo

    Subcutaneous Injection

06

What researchers measure

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

07

Study locations

63 sites
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Data sharing details ↗ · www.pfizer.com

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Aug 2027, 14 months after the start.

Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 14 months is above that.

Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2026
First posted
May 8, 2026
StartActual
May 11, 2026
Primary completionEst.
Aug 4, 2027
CompletionEst.
Jan 5, 2028
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and site details
2 updates, last Nov 5, 2026
Show all 2 updates
  1. Nov 5, 2026
    Minor edits only
    + 2 other changes: verification date and site details
  2. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07575932
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 8, 2026
Start date
May 11, 2026
Primary completion
Aug 4, 2027 (estimated)
Completion
Jan 5, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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