Trial Outcomes & Findings for A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (NCT NCT04050553)
NCT ID: NCT04050553
Last Updated: 2024-05-20
Results Overview
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using restricted maximum likelihood (REML) method was used. PG of plateau 100 mg/dL was considered as baseline timepoint.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.
Results posted on
2024-05-20
Participant Flow
Participant milestones
| Measure |
Placebo/Tirzepatide 15 Milligrams (mg)
Period 1: Participants received placebo administered subcutaneously (SC) once-weekly (QW) for 12 weeks; Wash-out: 8-10 weeks; Period 2: Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
Tirzepatide 15 mg/Placebo
Period 1: Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks); Wash-out: 8-10 weeks; Period 2: Participants received placebo administered SC QW for 12 weeks.
|
|---|---|---|
|
Period 1
STARTED
|
21
|
21
|
|
Period 1
Received At Least One Dose of Study Drug
|
21
|
21
|
|
Period 1
COMPLETED
|
18
|
17
|
|
Period 1
NOT COMPLETED
|
3
|
4
|
|
Wash-out
STARTED
|
18
|
17
|
|
Wash-out
COMPLETED
|
18
|
15
|
|
Wash-out
NOT COMPLETED
|
0
|
2
|
|
Period 2
STARTED
|
18
|
15
|
|
Period 2
Received At Least One Dose of Study Drug
|
18
|
15
|
|
Period 2
COMPLETED
|
18
|
15
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo/Tirzepatide 15 Milligrams (mg)
Period 1: Participants received placebo administered subcutaneously (SC) once-weekly (QW) for 12 weeks; Wash-out: 8-10 weeks; Period 2: Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
Tirzepatide 15 mg/Placebo
Period 1: Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks); Wash-out: 8-10 weeks; Period 2: Participants received placebo administered SC QW for 12 weeks.
|
|---|---|---|
|
Period 1
Physician Decision
|
2
|
2
|
|
Period 1
Adverse Event
|
1
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Wash-out
Adverse Event
|
0
|
1
|
|
Wash-out
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo/Tirzepatide 15 mg
n=21 Participants
Period 1: Participants received placebo administered SC QW for 12 weeks; Wash-out: 8-10 weeks; Period 2: Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
Tirzepatide 15 mg/Placebo
n=21 Participants
Period 1: Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks); Wash-out: 8-10 weeks; Period 2: Participants received placebo administered SC QW for 12 weeks.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
Austria
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.Population: All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data for this outcome.
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using restricted maximum likelihood (REML) method was used. PG of plateau 100 mg/dL was considered as baseline timepoint.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=33 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Change in Mean Glucagon Concentration During Induced Hypoglycemia From Target Plasma Glucose (PG) Concentration of 100 Milligrams Per Deciliter (mg/dL) to a Nadir Target of 45 mg/dL
|
18.55 picomole per liter (pmol/L)
Standard Error 1.64
|
18.07 picomole per liter (pmol/L)
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.Population: All participants who received at least one dose of study drug and had evaluable PD data for this outcome.
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using REML method was used.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=33 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Change in Mean Insulin Concentrations From Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
-1053.31 picomole per liter (pmol/L)
Standard Error 54.20
|
-1228.08 picomole per liter (pmol/L)
Standard Error 53.61
|
SECONDARY outcome
Timeframe: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.Population: All participants who received at least one dose of study drug and had evaluable PD data for this outcome.
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using REML method was used.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=33 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Change in Mean C-peptide Concentrations From Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
-177.69 picomole per liter (pmol/L)
Standard Error 51.78
|
-665.99 picomole per liter (pmol/L)
Standard Error 51.09
|
SECONDARY outcome
Timeframe: Week 12 in each treatment period (treatment period = 12 weeks): 1 minute after reaching the nadir glucose level and when reaching normoglycemia (estimated as 30 mins).Population: All participants who received at least one dose of study drug and had evaluable PD data for this outcome.
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using REML method was used.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=32 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Time From Termination of Insulin Infusion at PG Concentration of 45 mg/dL to Reach Recovery PG Concentration (72 mg/dL)
|
43.34 minutes (min)
Standard Error 1.29
|
47.73 minutes (min)
Standard Error 1.27
|
SECONDARY outcome
Timeframe: Week 12.Population: All participants who received at least one dose of study drug and had evaluable PD data for this outcome.
Hypoglycemia symptoms score was measured with the Edinburgh Hypoglycemia Symptom Scale (EHSS) which is a 13-item questionnaire for hypoglycemic symptoms: 10 neuroglycopenic symptoms (6 cognitive dysfunctions: inability to concentrate, blurred vision, anxiety, confusion, difficulty speaking, and double vision; 4 neuroglycopenia: drowsiness, tiredness, hunger, and weakness), and 3 autonomic symptoms (sweating, trembling, and warmness) and participants were asked to rate the intensity of their hypoglycemic symptoms on a 7-point Likert scale (1 = No symptom to 7 = Severe). The total score is the sum of scores from the 13 questions and ranged from 13 to 91. This score was scaled back to the range of 1 to 7 by taking average of the sum of scores (i.e., sum of the scores divided by number of questions), where lower score indicates fewer symptoms.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=33 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Hypoglycemia Symptoms Score From Induced Hypoglycemia at Target PG Concentrations of 100 mg/dL, 63 mg/dL, 45 mg/dL and Recovery (PG Concentration 72 mg/dL)
45 mg/dL
|
1.68 Score on a scale
Standard Error 0.08
|
1.49 Score on a scale
Standard Error 0.08
|
|
Hypoglycemia Symptoms Score From Induced Hypoglycemia at Target PG Concentrations of 100 mg/dL, 63 mg/dL, 45 mg/dL and Recovery (PG Concentration 72 mg/dL)
72 mg/dL
|
1.50 Score on a scale
Standard Error 0.09
|
1.38 Score on a scale
Standard Error 0.09
|
|
Hypoglycemia Symptoms Score From Induced Hypoglycemia at Target PG Concentrations of 100 mg/dL, 63 mg/dL, 45 mg/dL and Recovery (PG Concentration 72 mg/dL)
63 mg/dL
|
1.35 Score on a scale
Standard Error 0.06
|
1.17 Score on a scale
Standard Error 0.06
|
|
Hypoglycemia Symptoms Score From Induced Hypoglycemia at Target PG Concentrations of 100 mg/dL, 63 mg/dL, 45 mg/dL and Recovery (PG Concentration 72 mg/dL)
100 mg/dL
|
1.19 Score on a scale
Standard Error 0.03
|
1.13 Score on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.Population: All participants who received at least one dose of study drug and had evaluable PD data for this outcome.
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using REML method was used.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=33 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Mean Change in Blood Pressure From Induced Hypoglycemia Target PG Nadir Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
Systolic Blood Pressure
|
-5.01 millimeters of Mercury (mmHg)
Standard Error 2.22
|
-5.51 millimeters of Mercury (mmHg)
Standard Error 2.17
|
|
Mean Change in Blood Pressure From Induced Hypoglycemia Target PG Nadir Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
Diastolic Blood Pressure
|
-9.84 millimeters of Mercury (mmHg)
Standard Error 1.16
|
-7.88 millimeters of Mercury (mmHg)
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level.Population: All participants who received at least one dose of study drug and had evaluable PD data for this outcome.
A linear mixed effects model, with treatment, treatment period, and treatment sequence as fixed effects, and patient as a random effect using REML method was used.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=33 Participants
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Mean Change in Heart Rate From Induced Hypoglycemia Target PG Concentration of 100 mg/dL to a Nadir Target of 45 mg/dL
|
5.56 beats per minute (beats/min)
Standard Error 1.26
|
4.67 beats per minute (beats/min)
Standard Error 1.23
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Tirzepatide 15 mg
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=39 participants at risk
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
2.6%
1/39 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
2.6%
1/39 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
2.6%
1/39 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
2.6%
1/39 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received placebo administered SC QW for 12 weeks.
|
Tirzepatide 15 mg
n=39 participants at risk
Participants received a starting dose of 2.5 mg tirzepatide given SC QW for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks).
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
3/36 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.3%
4/39 • Number of events 5 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
5.1%
2/39 • Number of events 3 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.8%
1/36 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
12.8%
5/39 • Number of events 5 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.3%
4/39 • Number of events 5 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
4/36 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
17.9%
7/39 • Number of events 9 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
15.4%
6/39 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.3%
4/39 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
5.1%
2/39 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
38.5%
15/39 • Number of events 27 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
1/36 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
15.4%
6/39 • Number of events 8 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Injection site reaction
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
7.7%
3/39 • Number of events 7 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
7.7%
3/39 • Number of events 3 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Pancreatic enzymes increased
|
2.8%
1/36 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
7.7%
3/39 • Number of events 3 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
15.4%
6/39 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/39 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.3%
4/39 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
5.1%
2/39 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
17.9%
7/39 • Number of events 9 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/36 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
5.1%
2/39 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 36 Weeks)
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60