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ObesityOUTSTEP-1NCT07154238

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

An observational study of Obesity, run by Novo Nordisk A/S at 1 site in Germany.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
No treatment given
How many people
2,546 participants
Where
1 siteGermany
Study dates
26 Sep 2025to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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".
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Germany1 site
  • Novo Nordisk Investigational Site

    Bad Oeynhausen, 32545

Other trials in Germany

About this 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.

Conditions
Obesity
Being tested
No treatment given
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

    No treatment given

Study groups in NCT07154238
Study groupRoleWhat they receive
Baseline0 - 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.
Receives: Other: No treatment given
End of Escalation Phase16 - 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.
Receives: Other: No treatment given
Weight Loss Phase48 - 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
Receives: Other: No treatment given
Stable Weight PhaseMore 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.
Receives: Other: No treatment given
Healthcare Providers (HCP)sHCPs 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.
Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: At the time of survey response (Day 1)

Secondary outcomes (32)
  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

    Measured: 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

    Measured: 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

    Measured: At the time of survey response (Day 1)

  4. Expected benefits of injectable semaglutide

    Patient Quantitative Segment Multi select from a defined list

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: At the time of survey response (Day 1)

  31. Number of treatment pauses

    Patient Quantitative Segment Numeric entry

    Measured: 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

    Measured: At the time of survey response (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start26 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
2,546 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154238
Sponsor's protocol ID
NN9536-8412
Other IDs
U1111-1314-6149
Acronym
OUTSTEP-1
Status last verified
Nov 2025
First submitted
26 Aug 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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