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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05064735
Collaborator
(none)
375
Enrollment
64
Locations
2
Arms
20.3
Anticipated Duration (Months)
5.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: semaglutide 2.4 mg
  • Drug: semaglutide 2.4 mg (placebo)
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Apr 25, 2023
Anticipated Study Completion Date :
Jun 12, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: semaglutide 2.4 mg

Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity

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

Placebo Comparator: semaglutide 2.4 mg (placebo)

Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. Change in body weight [From baseline (week 0) to end of treatment (week 68)]

    Percentage

  2. Change in WOMAC pain score [From baseline (week 0) to end of treatment (week 68)]

    Score points

Secondary Outcome Measures

  1. Achieving body weight reduction greater than or equal to 5% (yes/no) [From baseline (week 0) to end of treatment (week 68)]

    Count of subjects

  2. Achieving body weight reduction greater than or equal to 10% (yes/no) [From baseline (week 0) to end of treatment (week 68)]

    Count of subjects

  3. Change in WOMAC physical function score [From baseline (week 0) to end of treatment (week 68)]

    Score points

  4. Change in SF-36 physical functioning score [From baseline (week 0) to end of treatment (week 68)]

    Score points

  5. Change in waist circumference [From baseline (week 0) to end of treatment (week 68)]

    cm

  6. Change in WOMAC stiffness score [From baseline (week 0) to end of treatment (week 68)]

    Score points

  7. Change in WOMAC total score [From baseline (week 0) to end of treatment (week 68)]

    Score points

  8. Change in SF-36 bodily pain score [From baseline (week 0) to end of treatment (week 68)]

    Score points

  9. Change in SF-36 physical component summary [From baseline (week 0) to end of treatment (week 68)]

    Score points

  10. Change in SF-36 mental component summary [From baseline (week 0) to end of treatment (week 68)]

    Score points

  11. Use of allowed rescue analgesics during wash out [From baseline (week 0) to end of treatment (week 68)]

    Count of subjects

  12. Amount of allowed rescue analgesics used during wash out [From baseline (week 0) to end of treatment (week 68)]

    Dose

  13. Change in pain medication [From baseline (week 0) to end of treatment (week 68)]

    Dose

  14. Change in pain intensity (NRS) [From baseline (week 0) to end of treatment (week 68)]

    Score points

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteMontgomeryAlabamaUnited States36106
2Novo Nordisk Investigational SitePalm SpringsCaliforniaUnited States92262
3Novo Nordisk Investigational SiteWalnut CreekCaliforniaUnited States94598
4Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32205
5Novo Nordisk Investigational SiteOcalaFloridaUnited States34470
6Novo Nordisk Investigational SiteHonoluluHawaiiUnited States96814
7Novo Nordisk Investigational SiteEvanstonIllinoisUnited States60201-2477
8Novo Nordisk Investigational SiteGurneeIllinoisUnited States60031
9Novo Nordisk Investigational SiteLouisvilleKentuckyUnited States40213
10Novo Nordisk Investigational SiteTroyMichiganUnited States48098
11Novo Nordisk Investigational SiteSaint LouisMissouriUnited States63141
12Novo Nordisk Investigational SiteWest SenecaNew YorkUnited States14224
13Novo Nordisk Investigational SiteWestfieldNew YorkUnited States14787
14Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
15Novo Nordisk Investigational SiteFranklinOhioUnited States45005
16Novo Nordisk Investigational SiteNorth CharlestonSouth CarolinaUnited States29405
17Novo Nordisk Investigational SiteHoustonTexasUnited States77024
18Novo Nordisk Investigational SiteNewport NewsVirginiaUnited States23606
19Novo Nordisk Investigational SiteSurreyBritish ColumbiaCanadaV3Z 2N6
20Novo Nordisk Investigational SiteHamiltonOntarioCanadaL8L 5G8
21Novo Nordisk Investigational SiteHamiltonOntarioCanadaL8M 1K7
22Novo Nordisk Investigational SiteLondonOntarioCanadaN5W 6A2
23Novo Nordisk Investigational SiteTorontoOntarioCanadaM9V 4B4
24Novo Nordisk Investigational SiteMontrealQuebecCanadaH4N 2W2
25Novo Nordisk Investigational SiteBarranquillaColombia80020
26Novo Nordisk Investigational SiteBogotaColombia110221
27Novo Nordisk Investigational SiteBogotaColombia110221
28Novo Nordisk Investigational SiteChiaColombia250001
29Novo Nordisk Investigational SiteAarhus NDenmark8200
30Novo Nordisk Investigational SiteFrederiksbergDenmark2000
31Novo Nordisk Investigational SiteClermont-FerrandFrance63000
32Novo Nordisk Investigational SitePARIS cedex 13France75651
33Novo Nordisk Investigational SiteParisFrance75908
34Novo Nordisk Investigational SitePierre BeniteFrance69310
35Novo Nordisk Investigational SiteTOULOUSE cedexFrance31054
36Novo Nordisk Investigational SiteNordbyhagenNorway1474
37Novo Nordisk Investigational SiteOsloNorway0586
38Novo Nordisk Investigational SiteTønsbergNorway3117
39Novo Nordisk Investigational SiteKazanRussian Federation420061
40Novo Nordisk Investigational SiteKemerovoRussian Federation650070
41Novo Nordisk Investigational SiteMoscowRussian Federation119435
42Novo Nordisk Investigational SiteMoscowRussian Federation127486
43Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation197110
44Novo Nordisk Investigational SiteSaratovRussian Federation410002
45Novo Nordisk Investigational SiteTomskRussian Federation634050
46Novo Nordisk Investigational SiteVoronezhRussian Federation394018
47Novo Nordisk Investigational SiteYaroslavlRussian Federation150040
48Novo Nordisk Investigational SiteAl AhsaSaudi Arabia36428
49Novo Nordisk Investigational SiteRiyadhSaudi Arabia11525
50Novo Nordisk Investigational SiteRiyadhSaudi Arabia12372
51Novo Nordisk Investigational SiteRiyadhSaudi Arabia12713
52Novo Nordisk Investigational SitePort ElizabethEastern CapeSouth Africa6001
53Novo Nordisk Investigational SiteBoksburgGautengSouth Africa1466
54Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa2013
55Novo Nordisk Investigational SitePretoriaGautengSouth Africa0122
56Novo Nordisk Investigational SiteDurbanKwaZulu-NatalSouth Africa4001
57Novo Nordisk Investigational SiteStanger, DurbanKwaZulu-NatalSouth Africa4450
58Novo Nordisk Investigational SiteLa CoruñaSpain15006
59Novo Nordisk Investigational SiteMadridSpain28040
60Novo Nordisk Investigational SiteSevillaSpain41003
61Novo Nordisk Investigational SiteMalmöSweden205 02
62Novo Nordisk Investigational SiteStockholmSweden112 81
63Novo Nordisk Investigational SiteStockholmSweden141 86
64Novo Nordisk Investigational SiteÖrebroSweden701 85

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT05064735
Other Study ID Numbers:
  • NN9536-4578
  • U1111-1246-5824
  • 2020-000204-11
First Posted:
Oct 1, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021