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OpenTrials
Enrolling by Invitation

NCT Number: NCT07154238

Characteristics and Treatment Experiences of Individuals Using Injectable Semaglutide for Weight Management, a Cross-sectional Time-series Analysis, Multi-country Study.

The purpose of this study is to collect information for scientific research and to better understand the experiences of participants managing their weight. The study aims to collect valid responses through online interviews from participants. This study is a survey-based study without collection of laboratory data. Duration of the study will be about 14 months.

Enrolling by Invitation

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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

Novo Nordisk Investigational Site

Bad Oeynhausen, 32545, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • For an eligible participant (individuals initiated on injectable semaglutide for weight management), all inclusion criteria must be answered "yes".
  • Electronically provided consent obtained before any study-related activities can be completed.
  • Age above or equal to 18 years at the time of providing informed consent.
  • Reside in a participating country: Australia, Germany, United Arab Emirates (UAE) and Spain.
  • Have been prescribed and initiated injectable semaglutide for weight management prior to study screening.
  • For an eligible participant (HCPs), all inclusion criteria must be answered "yes".
  • Electronically provided consent obtained before any study-related activities can be completed.
  • Practice in a participating country: Australia, Germany, UAE, and Spain.
  • See at least 150 patients for any condition per month; priority given to those who treat at least 200 patients for any condition per month.
  • Treat at least 10 adult patients per month for weight management.
  • Prescribe anti-obesity medications (AOMs) to their patients they personally treat for weight management/obesity care; priority given to those who treat at least 10% of the patients they personally treat for weight management/obesity care with anti-obesity medications (AOMs).
  • Prescribe injectable semaglutide for weight management.
  • Be a specialty of interest (varies by country); mix of primary care, specialists such as Endocrinologists, Diabetologists, Nutrition Specialists, Obesity Specialists and others.

Exclusion criteria

  • For an eligible participant (individuals initiated on injectable semaglutide for weight management), all exclusion criteria must be answered "no".
  • Unwillingness or language barriers precluding adequate understanding or cooperation.
  • Is currently or planning to become pregnant in next six months.
  • Is taking injectable semaglutide for Type 2 diabetes management only.
  • For an eligible participant (HCPs), all exclusion criteria must be answered "no".
  • Prior participation in this study. Participation is defined as having given informed consent and submitting responses to an interview.
  • Unwillingness or language barriers precluding adequate understanding or cooperation.
  • Only treats patients under 18 years of age.

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

  1. Description of characteristics, including clinical, demographic and physical characteristics, among individuals initiated on injectable semaglutide for weight management

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list Single select from a defined list Numeric entry Open-ended type-in Patient Qualitative Segment Open-ended commentary

  2. Description of the experience of individuals initiated on injectable semaglutide for weight management through personal perception of physical and mental health and self-reported QoL

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates extremely dissatisfied and 7 indicates extremely satisfied) Single select from a defined list EQ-5D-5L Patient Qualitative Segment Open-ended commentary

  3. Individual-reported change in BMI since initiation

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Numeric entry (BMI calculated based on self-reported height and weight)

  4. Individual-reported achievement of weight loss goal

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Yes/No; percentage of weight loss goal achieved Patient Qualitative Segment Open-ended commentary

  5. Individual-reported change in weight since initiation

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Numeric entry in (kgs); percentage of weight change Patient Qualitative Segment Open-ended commentary

  6. Individual-reported changes in daily life since initiation on injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Qualitative Segment Open-ended commentary

Secondary outcomes

  1. Treatment expectation of individuals initiated on injectable semaglutide of ability to achieve weight loss goal using injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates not at all confident and 7 indicates extremely confident) Patient Qualitative Segment Open-ended commentary

  2. Expectation for length of time of treatment to desired result from date of initiation on injectable semaglutide at baseline

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Numeric entry months Patient Qualitative Segment Open-ended commentary

  3. Expectation of individuals initiated on injectable semaglutide for weight management who believe they will have greater success in achieving their weight loss with the use of injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Patient Qualitative Segment Open-ended commentary

  4. Expected benefits of injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list

  5. Satisfaction with weight loss since initiation

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for satisfaction (where 1 indicates extremely dissatisfied all and 7 indicates extremely satisfied) Patient Qualitative Segment Open-ended commentary

  6. Overall satisfaction with injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for satisfaction (where 1 indicates extremely dissatisfied all and 7 indicates extremely satisfied) Patient Qualitative Segment Open-ended commentary

  7. Individual-reported changes in perception of injectable semaglutide since initiation

    Time frame: At the time of survey response (Day 1)

    Patient Qualitative Segment Open-ended commentary

  8. Attitudes of individuals related to obesity or weight related stigmatization or discrimination prior to/since/due to initiation on injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list

  9. Attitudes of individuals initiated on injectable semaglutide for weight management related to obesity as a chronic disease

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree)

  10. Attitudes of individuals initiated on injectable semaglutide for weight management related to weight loss being their responsibility

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree)

  11. Attitudes of individuals initiated on injectable semaglutide for weight management related to weight loss being more likely with use of prescription medication for weight loss (AOMs)

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree)

  12. Degree of knowledge of individuals initiated on injectable semaglutide for weight management related to how prescription weight loss medications (AOMs) work in the body

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Patient Qualitative Segment Open-ended commentary

  13. Behaviours of individuals initiated on injectable semaglutide for weight management related to making lifestyle changes in addition to initiating on injectable semaglutide for weight loss or weight management to achieve their weight loss goals

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list Patient Qualitative Segment Open-ended commentary

  14. Attitudes of individuals initiated injectable semaglutide for weight management related to the necessity to make lifestyle changes in addition to initiating injectable semaglutide for weight loss or weight management to achieve their weight loss goals

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Patient Qualitative Segment Open-ended commentary

  15. Attitudes of individuals who initiated on injectable semaglutide for weight management relating to ease of maintaining lifestyle changes (e.g., eating a healthy diet and getting regular exercise) since initiating on injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree)

  16. Individual-reported change in overall knowledge of how AOMs work from initiation on injectable semaglutide to present day

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree)

  17. Attitudes related to viewing obesity as a chronic disease

    Time frame: At the time of survey response (Day 1)

    HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary

  18. Attitudes related to belief weight loss is solely an individual's responsibility

    Time frame: At the time of survey response (Day 1)

    HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary

  19. Attitudes related to belief weight loss requires use of prescription medication for weight loss (AOMs)

    Time frame: At the time of survey response (Day 1)

    HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary

  20. Attitudes related to belief individuals must make lifestyle changes in addition to initiating on injectable semaglutide for weight loss or weight management to achieve their weight loss goals

    Time frame: At the time of survey response (Day 1)

    HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary

  21. Attitudes related to belief individuals will have greater success in achieving their weight loss goals with use of injectable semaglutide

    Time frame: At the time of survey response (Day 1)

    HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary

  22. Attitudes related to level of comfort prescribing AOMs and injectable semaglutide specifically for weight management

    Time frame: At the time of survey response (Day 1)

    HCP Qualitative Segment 7-point Likert scales for agreement (where 1 indicates strongly disagree and 7 indicates strongly agree) Open-ended commentary

  23. Reasons for length of adherence

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list Patient Qualitative Segment Open-ended commentary

  24. Future planned use of injectable semaglutide (among current users)

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list; Numeric entry months Patient Qualitative Segment Open-ended commentary

  25. Reasons for discontinuation (among those who discontinued)

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Multi select from a defined list Patient Qualitative Segment Open-ended commentary

  26. Likelihood to resume injectable semaglutide (specifically for weight management) after formal discontinuation and reasons

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for likelihood (where 1 indicates not at all likely and 7 indicates extremely likely) Multi select from a defined list Patient Qualitative Segment Open-ended commentary

  27. Individual-reported likelihood of continuation on injectable semaglutide until achieve goal weight and reasons

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for likelihood (where 1 indicates not at all likely and 7 indicates extremely likely)

  28. Likelihood of continuation on injectable semaglutide after achieving weight loss goal and reasons

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment 7-point Likert scale for likelihood (where 1 indicates not at all likely and 7 indicates extremely likely)

  29. Treatment pause initiated by individual and reasons

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Yes/No; Numeric entry; Multi select from a defined list Patient Qualitative Segment Open-ended commentary

  30. Treatment pause initiated by HCP and reasons

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Yes/No; Numeric entry; Multi select from a defined list Patient Qualitative Segment Open-ended commentary

  31. Number of treatment pauses

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Numeric entry

  32. Among those with low likelihood to use injectable semaglutide after discontinuation, potential use of another AOM

    Time frame: At the time of survey response (Day 1)

    Patient Quantitative Segment Yes/No/Not Sure

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: OUTSTEP-1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Nov 25, 2025

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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