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Enrolling by Invitation

NCT Number: NCT07055607

A Two-year Prospective, Observational Study of Wegovy in Real-world Clinical Practice

This observational study will explore how Wegovy® (Semaglutide) is used in everyday situations, how it might affect things like weight, body mass index (BMI) and waist circumference, and what kind of impact it could have on overall quality of life. The overall purpose of this study is to understand how Wegovy impacts weight when used as part of regular medical care. Participants will be treated with Wegovy as prescribed to the participant by their doctor, in accordance with normal clinical practice. The study will last for about two years.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CAP Sants, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed consent obtained before any study-related activities (study-related activities are any pro-cedure related to recording of data according to the protocol).
  • Are eligible for Wegovy and are due to initiate treatment for the first time within the study period; the decision to initiate treatment with commercially available Wegovy has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
  • Male or female, age above or equal to 18 years at time of signing informed consent.
  • Have at least one reported weight measurement documented at baseline or within 28 days prior to baseline.
  • Participants must be able to complete the electronic patient reported outcome (ePRO) questionnaires on a compatible electronic device with internet access.
  • Fulfil the respective reimbursement criteria in the visit prior to / at baseline in Switzerland and United Kingdom (UK).

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Presence of a documented refusal or unwillingness to participate in research.
  • Previous treatment with other obesity management pharmacotherapy or any glucagon like pep-tide-1 (GLP- 1) receptor agonist up to 90 days prior to baseline in Switzerland and UK.
  • Previous treatment with other obesity management pharmacotherapy or any GLP- 1 receptor agonist up to 30 days prior to baseline in Spain.
  • Pregnant or women of childbearing potential and not using a highly effective contraceptive method.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation with the study requirements.
  • Individuals who have reported plans to move out in the next 12 months to an area not serviced by their current site.
  • Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) in Spain and UK.
  • Participant has had a prior serious allergic reaction to semaglutide or any of the ingredients in Wegovy.
  • Have had Saxenda reimbursed by basic mandatory health insurance for a cumulative period of more than 12 months prior to baseline in Switzerland.
  • Documented history of diabetes mellitus type 1 and type 2 in Spain.
  • Presence of diabetic complications and/or at risk of hypoglycaemia (with a documented history of frequent hypoglycaemia) in Spain.

Treatment and study plan

semaglutide

Drug

Participants will be treated with commercially available Wegovy according to routine clinical practice and is purely at the discretion of the treating physician. Only individuals receiving Wegovy reimbursed by the healthcare system in their respective countries are included in the study.

Other names: Wegovy®

Primary outcomes

  1. Absolute change in body weight (kilograms [kg])

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in kg.

  2. Percentage change in body weight (percentage [%])

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in %.

Secondary outcomes

  1. Absolute change in waist circumference (centimeters [cm])

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in cm.

  2. Absolute change in waist-to-height ratio

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as ratio.

  3. Percentage change in waist circumference (%)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in %.

  4. Number of participants who achieve greater than or equal to (>=) 5 percent body weight reduction (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as count of participants.

  5. For Switzerland: Number of participants who achieve >=7 percent body weight reduction (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (22 months)

    Measured as count of participants.

  6. Number of participants who achieve >=10 percent body weight reduction (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as count of participants.

  7. For Switzerland: Number of participants who achieve >=12 percent body weight reduction (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (22 months)

    Measured as count of participants.

  8. Number of participants who achieve >=15 percent body weight reduction (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as count of participants.

  9. Number of participants who achieve >=20 percent body weight reduction (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as count of participants.

  10. Change in percentage of participant in each Body Mass Index (BMI) category

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as count of participants.

  11. Change in High Density Lipoprotein (HDL) Cholesterol (milligrams per decilitre [mg/dL])

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mg/dL.

  12. Change in HDL Cholesterol (millimoles per litre [mmol/L])

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mmol/L.

  13. Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mg/dL.

  14. Change in LDL Cholesterol (mmol/L)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mmol/L.

  15. Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mg/dL.

  16. Change in VLDL Cholesterol (mmol/L)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mmol/L.

  17. Change in Free Fatty Acid (FFA) (mmol/L)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mmol/L.

  18. Change in Triglycerides (mg/dL)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mg/dL.

  19. Change in Triglycerides (mmol/L)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mmol/L.

  20. Change in Glycated Haemoglobin (HbA1c) (%)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in %.

  21. Change in systolic blood pressure

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in millimeter of mercury (mmHg).

  22. Change in diastolic blood pressure

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in mmHg.

  23. Percentage change in the prevalence of obesity-related conditions

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Obesity-related conditions will be assessed as Yes/No in the following categories: Myocardial infarction (MI), Stroke, Heart failure with reduced Ejection Fraction (HFrEF) and Heart Failure with preserved Ejection Fraction (HFpEF), Atherosclerotic cardiovascular disease (ASCVD) defined as at least one of coronary artery disease, peripheral artery disease, cerebrovascular disease and atherosclerosis, Metabolic dysfunction-associated steatotic liver disease (MASLD), Metabolic dysfunction-associated steatohepatitis (MASH), Chronic kidney disease (CKD), Obstructive sleep apnoea, Poly-cystic ovary syndrome (PCOS), Infertility, Urinary incontinence, Lower back pain, Knee / hip oste-oarthritis, Musculoskeletal pain, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Clini-cian-diagnosed mood disorder, Clinician-diagnosed eating disorder.

  24. Percentage change in the total daily dosage of concomitant drugs (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Total daily dosage of concomitant drugs were assessed as Yes/No among the following: Antidiabetic medication, Antihypertensive medication, Lipid-lowering medication, Pain medica-tion, Psychotropic medication, Antithrombotic agents, Thyroid hormone medication, Proton pump inhibitor.

  25. Percentage change in the usage of additional treatments for weight loss (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Usage of additional treatments for weight loss will be assessed as Yes/No among the following: Bariatric surgery, Clinical practice / healthcare-provided diet plan, Alternative diet plan, Exercise regime, Behavioural and alternative therapy, Digital health app.

  26. Median time to Wegovy® maintenance dose

    Time frame: From baseline to the date of reported maintenance dose during the observation period (24 months)

    Measured in weeks.

  27. Median time to each Wegovy® dose escalation

    Time frame: Date from the start of the previous dose to the date of each subsequent escalation during the observation period (24 months)

    Measured in weeks.

  28. Maximum dose of Wegovy® for weight management

    Time frame: After baseline to any given time during the observation period (24 months)

    Measured in milligrams (mg).

  29. For UK and Spain: Change in percentage of participants on Wegovy® with each of drug-related adverse reaction

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as percentage of participants.

  30. Median persistence time of Wegovy® treatment

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured in weeks.

  31. Change in percentage of participants who discontinued

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as percentage of participants.

  32. Percentage of participants who discontinued/withdrawn

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as percentage of participants. Reason for discountinued/withdrawn due to Lack of efficacy as per reimbursement criteria (UK, CH only), Lack of efficacy as per clinical judgment, Lack of efficacy as per subject's judgment, Non-serious gastro intestinal event (nausea, vomiting, diarrhea, constipation and/or abdominal pain), Adverse reaction ((AR) not otherwise specified in the listed reasons), Patient's request, Pregnancy,Financial constraints (cost of medication, change in eligibility for reimbursement) (CH and ES only), Reaching a BMI of less than (<) 25 kilograms per meter square (kg/m^2), death and other.

  33. For Switzerland: Percentage of participants who continued under reimbursement by basic mandatory health insurance (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (22 months)

    Measured as percentage of participants.

  34. For Switzerland: Percentage of participants who switched to out-of-pocket payment (or any other arrangement) (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (22 months)

    Measured as percentage of participants.

  35. For Switzerland: Percentage of participants who stopped treatment (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (22 months)

    Measured as percentage of participants.

  36. For Spain: Percentage of participants who have continued under out-of-pocket payment (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (12 months)

    Measured as percentage of participants.

  37. For Spain: Percentage of participants who have switched to reimbursement by the Public Health System (Yes/No)

    Time frame: From baseline (0 months) to the end of observation (12 months)

    Measured as percentage of participants.

  38. For Switzerland: Change in percentage of participants fulfilling the necessary weight loss reimbursement criteria

    Time frame: From baseline (0 months) to the end of observation (22 months)

    Measured as percentage of participants.

  39. Absolute change in the EuroQoL-5-Dimension (5-Level) (EQ-5D-5L)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    EQ-5D-5L consists of 2 components, EQ-5D descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D 5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension will have 5 levels: no, slight, moderate, severe and extreme problems. Respondent is asked to indicate the health state by ticking the box next to the most appropriate statement in each of the five dimensions. Decision will result in a 1-digit number that expresses the level for that dimension. Digits for five dimensions can be combined into a 5-digit number that describes patient's health state. EQ-5D health states can be converted into a single summary number (index value) which will reflect how good/bad a health state is according to valuation set in general population of a country/region. Index score records an average health status according to dimensions using an algorithm,ranges 0-1 with higher score indicating better health status.

  40. Absolute change in the EQ Visual Analogue Score (EQ-VAS)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as score points. The EQ-VAS will record the respondent's self-rated health on a vertical visual analogue scale. The scale is numbered from 0 to 100, with lower score indicating worst health and higher score indicating best health.

  41. Absolute change in the Adelphi Adherence Questionnaire (ADAQ) score

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as score points. ADAQ is an 11-item instrument that measures adherence to medication. The instrument includes 4 items that assess adherence behaviours and 7 items that assess drivers of non adherence. Each item yields a score ranging from 0 to 4 and item scores are then averaged to produce the ADAQ score. The ADAQ score is a measure of medication adherence ranging from 0 to 4, with lower scores representing greater adherence.

  42. Absolute change in treatment satisfaction questionnaire for medication 9 (TSQM-9) domain scores

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as score points. TSQM-9 is a 9-item instrument that measures a patient's satisfaction with their medication. The instrument assesses three domains: effectiveness, convenience and global satisfaction. Each domain will produce a score ranging from 0 to 100, with higher scores reflecting higher satisfaction on that domain.

  43. Absolute change in percentage of work time missed (absenteeism) due to weight problem using Work Productivity and Activity Impairment Questionnaire (WPAI)

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as score points. WPAI is a self-administered instrument used to assess the impact of disease on work productivity and regular activities during the past seven days. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.

  44. Absolute change in percentage of time impaired while working (presenteeism) due to weight problem using WPAI

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as score points. WPAI is a self-administered instrument used to assess the impact of disease on work productivity and regular activities during the past seven days. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.

  45. Absolute change in percentage of activity impairment due to weight problem using WPAI

    Time frame: From baseline (0 months) to the end of observation (24 months)

    Measured as score points. WPAI is a self-administered instrument used to assess the impact of disease on work productivity and regular activities during the past seven days. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: PILLAR

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2025
Registry last updated
Jul 9, 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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