Trial Outcomes & Findings for A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease (NCT NCT04583735)
NCT ID: NCT04583735
Last Updated: 2024-07-01
Results Overview
Proptosis assessments were performed using a Hertel exophthalmometer. It measures the anterior projection of the eye from the lateral orbital rim to the cornea (proptosis).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Baseline, week 24
Results posted on
2024-07-01
Participant Flow
Results reported are for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023. Study consisted of double-masked treatment period (Week 24) and open label treatment period (Week 48).
Participant milestones
| Measure |
Teprotumumab
Participants received intravenous infusion of 10 milligrams per kilogram (mg/kg) teprotumumab at first infusion and then 20 mg/kg once every 3 weeks (Q3W) for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Placebo
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
|---|---|---|
|
Double-masked Treatment Period
STARTED
|
42
|
20
|
|
Double-masked Treatment Period
Intent-to-treat Populaton
|
42
|
20
|
|
Double-masked Treatment Period
Safety Analysis Population
|
41
|
20
|
|
Double-masked Treatment Period
COMPLETED
|
39
|
19
|
|
Double-masked Treatment Period
NOT COMPLETED
|
3
|
1
|
|
Open-label Treatment Period
STARTED
|
12
|
12
|
|
Open-label Treatment Period
COMPLETED
|
10
|
10
|
|
Open-label Treatment Period
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Teprotumumab
Participants received intravenous infusion of 10 milligrams per kilogram (mg/kg) teprotumumab at first infusion and then 20 mg/kg once every 3 weeks (Q3W) for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Placebo
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
|---|---|---|
|
Double-masked Treatment Period
Adverse Event
|
0
|
1
|
|
Double-masked Treatment Period
Lost to Follow-up
|
2
|
0
|
|
Double-masked Treatment Period
Withdrawal by Subject
|
1
|
0
|
|
Open-label Treatment Period
Adverse Event
|
1
|
1
|
|
Open-label Treatment Period
Withdrawal by Subject
|
1
|
0
|
|
Open-label Treatment Period
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
Baseline characteristics by cohort
| Measure |
Teprotumumab
n=42 Participants
Participants received intravenous infusion of 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Placebo
n=20 Participants
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 14.37 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 16.45 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 14.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Proptosis for study eye
|
24.60 Millimeter
STANDARD_DEVIATION 3.007 • n=5 Participants
|
24.00 Millimeter
STANDARD_DEVIATION 2.824 • n=7 Participants
|
24.40 Millimeter
STANDARD_DEVIATION 2.939 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 24Population: ITT Population with available data at specified time point
Proptosis assessments were performed using a Hertel exophthalmometer. It measures the anterior projection of the eye from the lateral orbital rim to the cornea (proptosis).
Outcome measures
| Measure |
Teprotumumab
n=39 Participants
Participants received intravenous infusion of 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Placebo
n=20 Participants
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
|---|---|---|
|
Change From Baseline in Proptosis of Study Eye at Week 24
|
-2.41 Millimieter (mm)
Standard Error 0.228
|
-0.92 Millimieter (mm)
Standard Error 0.323
|
Adverse Events
Teprotumumab
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teprotumumab
n=41 participants at risk
Participants received intravenous infusion of 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Placebo
n=20 participants at risk
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
|---|---|---|
|
Ear and labyrinth disorders
Conductive deafness
|
2.4%
1/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
0.00%
0/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
Other adverse events
| Measure |
Teprotumumab
n=41 participants at risk
Participants received intravenous infusion of 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
Placebo
n=20 participants at risk
Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Ear and labyrinth disorders
Ear discomfort
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Ear and labyrinth disorders
Hypoacusis
|
9.8%
4/41 • Number of events 4 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
0.00%
0/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Eye disorders
Blepharospasm
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Eye disorders
Eye irritation
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Eye disorders
Eye pain
|
12.2%
5/41 • Number of events 8 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Eye disorders
Eye pruritus
|
7.3%
3/41 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
0.00%
0/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Eye disorders
Vision blurred
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.5%
8/41 • Number of events 12 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
20.0%
4/20 • Number of events 6 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
General disorders
Fatigue
|
22.0%
9/41 • Number of events 11 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
General disorders
Influenza like illness
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
General disorders
Pain
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Infections and infestations
COVID-19
|
14.6%
6/41 • Number of events 6 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Infections and infestations
Furuncle
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
15.0%
3/20 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Investigations
Blood pressure increased
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Investigations
Glycosylated haemoglobin increased
|
7.3%
3/41 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
0.00%
0/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Investigations
Human chorionic gonadotropin increased
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.4%
1/41 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
41.5%
17/41 • Number of events 20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
15.0%
3/20 • Number of events 4 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 3 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Nervous system disorders
Dysgeusia
|
9.8%
4/41 • Number of events 4 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Nervous system disorders
Headache
|
17.1%
7/41 • Number of events 9 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
10.0%
2/20 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • Number of events 2 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.2%
5/41 • Number of events 5 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
0.00%
0/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • Number of events 4 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
0.00%
0/20 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
5.0%
1/20 • Number of events 1 • From first dose of study drug until week 24
Safety population included all participants who received at least one dose of study drug. AE data was reported for double-masked treatment period (24 weeks) based on the primary completion date of 17 Mar 2023.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER