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Clinical Trials List

Protocol NumberNN9536-4706

2023-09-15 - 2025-10-22

Phase III

Not yet recruiting2

Terminated3

Efficacy and safety of semaglutide 2.4 mg once-weekly in adults with overweight and obesity (STEP 12)

  • Sponsor

    台灣諾和諾德藥品故份有限公司

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/10/31

Investigators and Locations

Principal Investigator 周莒光

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Kuo-Chin Huang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Wen-Yuan Lin

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Yi-Ching Yang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Weu Wang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

overweight and obesity

Objectives

To demonstrate superiority of semaglutide 2.4 mg versus placebo, as an adjunct to a reduced-calorie diet and increased physical activity, with respect to relative change in body weight after 44 weeks of treatment, in adults with overweight and obesity.

Test Drug

Semaglutide B

Active Ingredient

Semaglutide
Semaglutide
Semaglutide
Semaglutide
Semaglutide

Dosage Form

solution for injection

Dosage

0.68 mg/mL
1.34 mg/mL
1.34 mg/mL
2.27 mg/mL
3.2 mg/mL

Endpoints

Relative change in body weight

Inclution Criteria

• Age ≥ 18 years at the time of signing informed consent.
• Body mass index (BMI) of ≥ 24 and < 28 kg/m2 with the presence of at least one
weight-related complication (treated or untreated): T2D, hypertension, dyslipidaemia,
obstructive sleep apnoea or cardiovascular disease or BMI ≥ 28 and < 30 kg/m2, with or
without weight-related complications at screening.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

• A self-reported change in body weight > 5 kg within 90 days before screening irrespective of
medical records.
• Treatment with any medication for the indication of obesity within the past 90 days before
screening.
• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary
thyroid carcinoma.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    242 participants