Weight Loss in Adults Using Semaglutide (Real-world Study)
Real-world Weight Outcomes in Adults Treated With Semaglutide s.c. 1.0 mg or 1.7 mg for Weight Management: a Non-interventional Cohort Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
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London, United Kingdom
- Recruiting
- Novo Nordisk Investigational Site
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Washington
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Seattle, Washington, United States, 98039
- Recruiting
- Novo Nordisk Investigational Site
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Initiation of semaglutide for weight management during the study period.
- Age more than or equal to (≥) 18 at treatment initiation
- Baseline body mass index (BMI) ≥27 and less than (<) 30 kilogram per meter square (kg/m^2) with at least one weight-related comorbidity, or BMI ≥30 kg/m^2.
- Other inclusion criteria as defined in the protocol are applicable.
Exclusion Criteria:
- Prior use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) based medication or other obesity management medication (OMMs).
- Bariatric surgery at baseline.
- Diabetes at baseline.
- Pregnancy at baseline.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Semaglutide
Adults initiating semaglutide in routine clinical care and assigned to 0.5, 1.0, 1.7 or 2.4 mg at approximately Week 20.
Participants are followed from treatment initiation up to 68 weeks using data collected during routine clinical practice.
No study-specific interventions, visits, or procedures are performed.
Data are derived from secondary use of routinely collected healthcare data.
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This is a retrospective, non-interventional study; therefore, no intervention was administered as part of the study.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body weight
Time Frame: From index date (day 0) to week 68 (day 476)
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Measured as kilogram (kg)
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From index date (day 0) to week 68 (day 476)
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Change in body weight
Time Frame: From index date (day 0) to week 68 (day 476)
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Measured as percentage (%)
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From index date (day 0) to week 68 (day 476)
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Proportion of individuals achieving a clinically meaningful weight loss
Time Frame: From index date (day 0) to week 68 (day 476)
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Binary (yes/no): estimated ≥5% reduction from baseline body weight
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From index date (day 0) to week 68 (day 476)
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NN9536-8874
- U1111-1338-2016 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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