Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis

Obesity Clinical Trial

Official title:

Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064735
• Other study ID #: NN9536-4578
• Secondary ID: U1111-1246-58242
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: September 8, 2023

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed.

At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: September 8, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female, age above or equal to 18 years at the time of signing informed consent

• Body Mass Index (BMI) equal to or greater than 30.0 kg/m^2

• Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg.

• Pain due to knee OA

Exclusion Criteria:

• Joint replacement in target knee

• Arthroscopy or injections into target knee within last 3 months prior to enrolment

• Any other joint disease in the target knee

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• semaglutide 2.4 mg
semaglutide subcutaneous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity
• semaglutide 2.4 mg (placebo)
semaglutide subcutanous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Locations

Country	Name	City	State
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	Milestone Research	London	Ontario
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Ocean West Research Clinic	Surrey	British Columbia
Canada	Dr. Anil K Gupta Medicine Professional Corporation	Toronto	Ontario
Colombia	Centro de investigación médico asistencial S.A.S	Barranquilla
Colombia	CentrodeInvestigaciónenReumatologíayEspecialidadesMédicas	Bogota
Colombia	Preventive Care S.A.S	Chia
Denmark	Klinik for Led og bindevævssygdomme	Aarhus N
Denmark	Frederiksberg Hospital - Parker Institutet (Artrose)	Frederiksberg
France	Centre Hospitalier de Clermont-Ferrand-Hopital Gabriel Montpied	Clermont-Ferrand
France	Ap-Hp-Hopital Europeen Georges Pompidou	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Aphp-Hopital La Pitie Salpetriere-3	PARIS cedex 13
France	CHU Pitié-Salpétrière	PARIS cedex 13
France	Hospices Civils de Lyon-Hopital Lyon Sud-1	Pierre Benite
France	Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2	Toulouse
Norway	Akershus Universitetssykehus	Nordbyhagen
Norway	Oslo us HF, Aker sykehus	Oslo
Norway	Senter for sykelig overvekt i Helse Sør-Øst	Tønsberg
Russian Federation	PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways	Kazan
Russian Federation	LLC Medical center "Maksimum Zdorovia"	Kemerovo
Russian Federation	Federal Bureau for Medical and Social Expertise	Moscow
Russian Federation	National Medical Research Center of Endocrinology	Moscow
Russian Federation	Setchenov First Moscow State Medical University	Moscow
Russian Federation	Consultative & Diagnostic Center with a Outpatient Hospital	Saint-Petersburg
Russian Federation	SIH "Saratov Regional Clinical Hospital for War Veterans"	Saratov
Russian Federation	Siberian State Medical University	Tomsk
Russian Federation	Vorornezh Regional Clinical Consultive-diagnostic Centre	Voronezh
Russian Federation	SBCI HC Yaroslavl region "Central City Hospital"	Yaroslavl
Saudi Arabia	King Abdulaziz Hospital-Al Ahsa-National Guard	Al Ahsa
Saudi Arabia	King Fahad Medical City	Riyadh
Saudi Arabia	King Faisal Specialist Hospital & Research Centre, Riyadh	Riyadh
Saudi Arabia	King Khaled University Hospital,King Saud Univ. Med. City	Riyadh
South Africa	Dr Wilhase's rooms	Boksburg	Gauteng
South Africa	Dr J Reddy	Durban	KwaZulu-Natal
South Africa	Maxwell Centre	Durban	KwaZulu-Natal
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	Botho ke Bontle Health Services	Pretoria	Gauteng
Spain	Complejo Hospitalario Universitario A Coruña	La Coruña
Spain	Hospital Clinico San Carlos	Madrid
Spain	Clínica Nuevas Tecnologías en Diabetes y Endocrinología	Sevilla
Sweden	Forskningsmottagning Internmedicin (tidigare KFE)	Malmö
Sweden	Medicinkliniken Överviktsenheten USÖ	Örebro
Sweden	Department of Metabolism and Endocrinology	Stockholm
Sweden	S:t Göran Sjukhus	Stockholm
United States	Cleveland Clinic_Cleveland	Cleveland	Ohio
United States	Prestige Clinical Research	Franklin	Ohio
United States	Clinical Invest Special_Gurnee	Gurnee	Illinois
United States	East West Medical Research Institute	Honolulu	Hawaii
United States	PrimeCare Medical Group	Houston	Texas
United States	Westside Center For Clinical Research	Jacksonville	Florida
United States	L-MARC Research Center	Louisville	Kentucky
United States	Baptist Health System	Montgomery	Alabama
United States	Health Res of Hampton Roads	Newport News	Virginia
United States	Coastal Carolina Res Ctr.	North Charleston	South Carolina
United States	Renstar Medical Research	Ocala	Florida
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Sundance Clinical Research LLC	Saint Louis	Missouri
United States	Evanston Premier Hlthcr Res	Skokie	Illinois
United States	Arcturus Healthcare, PLC.	Troy	Michigan
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Great Lakes Medical Research	Westfield	New York
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Denmark,  France,  Norway,  Russian Federation,  Saudi Arabia,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Percentage	From baseline (week 0) to end of treatment (week 68)
Primary	Change in WOMAC pain score	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Achieving body weight reduction greater than or equal to 5% (yes/no)	Count of subjects	From baseline (week 0) to end of treatment (week 68)
Secondary	Achieving body weight reduction greater than or equal to 10% (yes/no)	Count of subjects	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in WOMAC physical function score	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in SF-36 physical functioning score	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in waist circumference	cm	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in WOMAC stiffness score	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in WOMAC total score	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in SF-36 bodily pain score	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in SF-36 physical component summary	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in SF-36 mental component summary	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Use of allowed rescue analgesics during wash out	Count of subjects	From baseline (week 0) to end of treatment (week 68)
Secondary	Amount of allowed rescue analgesics used during wash out	Dose	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in pain medication	Dose	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in pain intensity (NRS)	Score points	From baseline (week 0) to end of treatment (week 68)