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Clinical Trials List

Protocol NumberNN9536-4706
Completed

2023-09-15 - 2025-10-22

Phase III

Recruiting5

ICD-10E66.09

Other obesity due to excess calories

ICD-10E66.1

Drug-induced obesity

ICD-10E66.8

Other obesity

ICD-10E66.9

Obesity, unspecified

ICD-9278.00

Obesity unspecified

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

  • Trial Applicant

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Sponsor

    台灣諾和諾德藥品股份有限公司

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 周莒光 Digestive System Department
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kuo-Chin Huang Division of Family Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Yuan Lin Division of Family Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Weu Wang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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

injection

Active Ingredient

Semaglutide

Dosage Form

230

Dosage

0.25mg, 0.5mg, 1.0mg, 1.7mg, 2.4mg

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

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