A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

NCT06041217 | Completed Phase 3 Results

• 2 other identifiers: NN9536-4706U1111-1273-4538
• Study Type: interventional
• Target: 242
• Locations: 2 countries
• Sites: 21

Brief Summary

This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight (%)

  Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.

  Baseline (week 0), end of treatment (week 44)

• Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

  Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.

  At end of treatment (week 44)

Secondary Outcomes (22)

• Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

  At end of treatment (week 44)

• Change in Waist Circumference

  Baseline (week 0), end of treatment (week 44)

• Change in Body Weight (kg)

  Baseline (week 0), end of treatment (week 44)

• Change in Body Mass Index

  Baseline (week 0), end of treatment (week 44)

• Change in Waist-height Ratio (WtHR)

  Baseline (week 0), end of treatment (week 44)

Study Arms (2)

Semaglutide 2.4 milligram (mg)

EXPERIMENTAL

Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.

Drug: Placebo

Interventions

Semaglutide DRUG

Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.

Semaglutide 2.4 milligram (mg)

Placebo DRUG

Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years at the time of signing informed consent.
• Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m\^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m\^2, with or without weight related complications at screening.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
• For participants with T2D at screening:
• \- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
• Treated with either:
• Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.
• Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening
• Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol \[mmol/mol\]) as measured by the central laboratory at screening.

You may not qualify if:

• A self-reported change in body weight greater than 5 kilograms (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.
• For participants without T2D at screening:
• \- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.
• For participants with T2D at screening:
• Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (21)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

Fujian Medical University Union Hospital-Endocrinology

Fuzhou, Fujian, 350001, China

Location

Huizhou Central People's Hospital-Endocrinology

Huizhou, Guangdong, 516001, China

Location

Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

Hengshui, Hebei, 053000, China

Location

Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology

Shiyan, Hubei, 442008, China

Location

Changzhou No.2 People's Hospital, Yanghu Branch

Changzhou, Jiangsu, 213003, China

Location

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

Location

The Second Affiliated Hospital of Nanjing Medical University_Nanjing

Nanjing, Jiangsu, 210011, China

Location

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

Location

The First Bethune hospital of Jilin University-Endocrinology

Changchun, Jilin, 130061, China

Location

Qinghai Provincial People's Hospital

Xining, Qinghai, 810007, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Shanghai Fifth People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 200240, China

Location

Tongren Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200336, China

Location

Shanghai Pudong New Area People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 201200, China

Location

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital_main

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: September 15, 2023
• Primary Completion: April 2, 2025
• Study Completion: May 7, 2025
• Last Updated: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (5); CN (16)