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Enrolling by invitationNCT07154238OUTSTEP-1Updated Nov 25, 2025

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

An observational study in Obesity, sponsored by Novo Nordisk A/S. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
2,546
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Obesity

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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 2,546 is above the median of 135 across 1,283 observational studies indexed under Obesity.

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Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will collect quantitative and qualitative data from individuals treated with injectable semaglutide for weight management in real-world settings.

The study will include two groups of participants:

  1. Individuals who belong to or are recruited to an opt-in panel in the countries of interest and who have initiated injectable semaglutide for weight management. They will be classified according to the time when they first initiated treatment with injectable semaglutide for weight management.
  2. HCPs who prescribe injectable semaglutide for weight management will be recruited from an existing opt-in panel in the countries of interest.

Inclusion criteria

  • For an eligible participant (individuals initiated on injectable semaglutide for weight management), all inclusion criteria must be answered "yes".

    1. Electronically provided consent obtained before any study-related activities can be completed.
    2. Age above or equal to 18 years at the time of providing informed consent.
    3. Reside in a participating country: Australia, Germany, United Arab Emirates (UAE) and Spain.
    4. 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".

    1. Electronically provided consent obtained before any study-related activities can be completed.
    2. Practice in a participating country: Australia, Germany, UAE, and Spain.
    3. 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.
    4. Treat at least 10 adult patients per month for weight management.
    5. 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).
    6. Prescribe injectable semaglutide for weight management.
    7. 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

Exclusion Criteria:

  • For an eligible participant (individuals initiated on injectable semaglutide for weight management), all exclusion criteria must be answered "no".

    1. Unwillingness or language barriers precluding adequate understanding or cooperation.
    2. Is currently or planning to become pregnant in next six months.
    3. Is taking injectable semaglutide for Type 2 diabetes management only.
  • For an eligible participant (HCPs), all exclusion criteria must be answered "no".

    1. Prior participation in this study. Participation is defined as having given informed consent and submitting responses to an interview.
    2. Unwillingness or language barriers precluding adequate understanding or cooperation.
    3. Only treats patients under 18 years of age.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
2,546 participants (estimated)
Patient registry
No

Groups and cohorts

  • Baseline

    0 - 8 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is no more than eight weeks prior to the date that they complete the screener to participate in the study.

    Other: No treatment given

  • End of Escalation Phase

    16 - 24 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is at least 16 weeks but no more than 24 weeks prior to the date that they complete the screener to participate in the study.

    Other: No treatment given

  • Weight Loss Phase

    48 - 56 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is at least 48 weeks but no more than 56 weeks prior to the date that they complete the screener to participate in the study

    Other: No treatment given

  • Stable Weight Phase

    More than or equal to (≥) 68 weeks post-initiation, individuals who self-reported an initiation date as day, month and year combination that is at least 68 weeks prior to the date that they complete the screener to participate in the study.

    Other: No treatment given

  • Healthcare Providers (HCP)s

    HCPs will be recruited from an opt-in panel available in each country which includes the practitioners representing different settings of obesity care. Qualified HCPs will be invited to participate in a one-on-one IDI with a moderator from each of the participating countries.

    Other: No treatment given

Interventions

  • OtherNo treatment given

    No treatment given

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What researchers measure

Primary outcomes

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

    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

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

  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

    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

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

  3. Individual-reported change in BMI since initiation

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

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

  4. Individual-reported achievement of weight loss goal

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

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

  5. Individual-reported change in weight since initiation

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

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

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

    Patient Qualitative Segment Open-ended commentary

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

Secondary outcomes

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

    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

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

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

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

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

  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

    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

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

  4. Expected benefits of injectable semaglutide

    Patient Quantitative Segment Multi select from a defined list

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

  5. Satisfaction with weight loss since initiation

    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

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

  6. Overall satisfaction with injectable semaglutide

    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

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

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

    Patient Qualitative Segment Open-ended commentary

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

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

    Patient Quantitative Segment Multi select from a defined list

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

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

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

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

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

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

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

  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)

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

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

  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

    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

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

  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

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

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

  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

    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

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

  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

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

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

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

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

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

  17. Attitudes related to viewing obesity as a chronic disease

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

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

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

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

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

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

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

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

  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

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

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

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

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

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

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

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

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

  23. Reasons for length of adherence

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

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

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

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

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

  25. Reasons for discontinuation (among those who discontinued)

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

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

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

    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

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

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

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

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

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

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

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

  29. Treatment pause initiated by individual and reasons

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

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

  30. Treatment pause initiated by HCP and reasons

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

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

  31. Number of treatment pauses

    Patient Quantitative Segment Numeric entry

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

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

    Patient Quantitative Segment Yes/No/Not Sure

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

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Bad Oeynhausen, 32545, Germany
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References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07154238
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 4, 2025
Start date
Sep 26, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Nov 25, 2025

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

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

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