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Active, Not Recruiting

NCT Number: NCT07311850

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MHAT Botevgrad, Botevgrad, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to <30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

Exclusion criteria

  • Have any form of diabetes
  • Have a self-reported body weight change > 5 kg (11 pounds) within 3 months prior to Screening
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

Treatment and study plan

MET097

Drug

Once-weekly MET097 administered via subcutaneous injection

Other names: PF-08653944

Placebo

Drug

Once-weekly placebo administered via subcutaneous injection

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline (Day 0) to Week 64

Secondary outcomes

  1. Percentage of Participants who achieve ≥5% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 64

  2. Percentage of Participants who achieve ≥10% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 64

  3. Percentage of Participants who achieve ≥15% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 64

  4. Percentage of Participants who achieve ≥20% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 64

  5. Change from baseline in Fasting triglycerides

    Time frame: Baseline (Day 0) to Week 64

  6. Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)

    Time frame: Baseline (Day 0) to Week 64

  7. Change from baseline in systolic blood pressure

    Time frame: Baseline (Day 0) to Week 64

  8. Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score

    Time frame: Baseline (Day 0) to Week 64

  9. Change from baseline in body weight

    Time frame: Baseline (Day 0) to Week 84

  10. Percentage of Participants who achieve ≥5% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 84

  11. Percentage of Participants who achieve ≥10% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 84

  12. Percentage of Participants who achieve ≥15% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 84

  13. Percentage of Participants who achieve ≥20% of reduction from baseline body weight

    Time frame: Baseline (Day 0) to Week 84

  14. Change from baseline in Fasting triglycerides

    Time frame: Baseline (Day 0) to Week 84

  15. Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C)

    Time frame: Baseline (Day 0) to Week 84

  16. Change from baseline in systolic blood pressure (mmHg)

    Time frame: Baseline (Day 0) to Week 84

  17. Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score

    Time frame: Baseline (Day 0) to Week 84

  18. Change from baseline in waist circumference (cm)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  19. Change from baseline in glycated hemoglobin (HbA1c)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  20. Change from baseline in fasting plasma glucose (FPG)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  21. Change from baseline in fasting insulin

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  22. Change from baseline in total cholesterol

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  23. Change from baseline in low-density lipoprotein-cholesterol (LDL-C)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  24. Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  25. Change from baseline in high-density lipoprotein-cholesterol (HDL-C)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  26. Change from baseline in DBP

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  27. Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  28. Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  29. Change from baseline in Control of Eating Questionnaire (CoEQ)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  30. Change from baseline in Food Noise Questionnaire (FNQ)

    Time frame: Baseline (Day 0) to Week 64 and Week 84

  31. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Week 84

  32. Number of Participants with Serious adverse events (SAEs)

    Time frame: Week 84

  33. Number of Participants with Adverse Events of Clinical Interest (AECIs

    Time frame: Week 84

  34. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Week 84

  35. Number of participants with anti-drug antibodies (ADAs)

    Time frame: Week 84

  36. Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944

    Time frame: Week 84

  37. Change from baseline in body weight

    Time frame: Baseline (Day 0) to Week 64

  38. Percent change from baseline in body weight

    Time frame: Baseline (Day 0) to Week 84

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Evaluating The Efficacy and Safety of MET097, a Fully-Biased, Ultra Long-Acting GLP-1RA, In People With Overweight or Obesity: A Phase 3, Multi-Center Randomized, Controlled Trial (VESPER-4)

Acronym: VESPER-4

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 31, 2025
Registry last updated
Jul 24, 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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