Characteristics and Treatment Experiences of Individuals Using Injectable Semaglutide for Weight Management, a Cross-sectional Time-series Analysis, Multi-country Study.
OUTSTEP-1
2 other identifiers
observational
2,546
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
September 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
November 25, 2025
November 1, 2025
1 year
August 26, 2025
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
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
At the time of survey response (Day 1)
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
At the time of survey response (Day 1)
Individual-reported change in BMI since initiation
Patient Quantitative Segment Numeric entry (BMI calculated based on self-reported height and weight)
At the time of survey response (Day 1)
Individual-reported achievement of weight loss goal
Patient Quantitative Segment Yes/No; percentage of weight loss goal achieved Patient Qualitative Segment Open-ended commentary
At the time of survey response (Day 1)
Individual-reported change in weight since initiation
Patient Quantitative Segment Numeric entry in (kgs); percentage of weight change Patient Qualitative Segment Open-ended commentary
At the time of survey response (Day 1)
Individual-reported changes in daily life since initiation on injectable semaglutide
Patient Qualitative Segment Open-ended commentary
At the time of survey response (Day 1)
Secondary Outcomes (32)
Treatment expectation of individuals initiated on injectable semaglutide of ability to achieve weight loss goal using injectable semaglutide
At the time of survey response (Day 1)
Expectation for length of time of treatment to desired result from date of initiation on injectable semaglutide at baseline
At the time of survey response (Day 1)
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
At the time of survey response (Day 1)
Expected benefits of injectable semaglutide
At the time of survey response (Day 1)
Satisfaction with weight loss since initiation
At the time of survey response (Day 1)
- +27 more secondary outcomes
Study Arms (5)
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.
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.
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
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.
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.
Interventions
No treatment given
Eligibility Criteria
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.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Bad Oeynhausen, 32545, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2025
First Posted
September 4, 2025
Study Start
September 26, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com