Characteristics and Treatment Experiences of Individuals Using Injectable Semaglutide for Weight Management, a Cross-sectional Time-series Analysis, Multi-country Study. (OUTSTEP-1)

Novo Nordisk

Status: Invitation-only

Conditions: Obesity

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT07154238

U1111-1314-6149 (Other Identifier)

NN9536-8412

Details and patient eligibility

About

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.

Enrollment: 2,546 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

2,546 participants in 5 patient groups

Baseline

Description:

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.

Treatment:

Other: No treatment given

End of Escalation Phase

Description:

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.

Treatment:

Other: No treatment given

Weight Loss Phase

Description:

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

Treatment:

Other: No treatment given

Stable Weight Phase

Description:

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.

Treatment:

Other: No treatment given

Healthcare Providers (HCP)s

Description:

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.

Treatment:

Other: No treatment given