Trial Outcomes & Findings for Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin (NCT NCT03684642)

Last Updated: 2021-11-01

Results Overview

Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

908 participants

Primary outcome timeframe

Baseline to Week 56

Results posted on

2021-11-01

Participant Flow

The study was conducted at 45 active sites in 4 countries. A total of 1608 participants were screened between 26 September 2018 and 17 December 2019, out of which 700 were screen failures. Screen failures were mainly due to inclusion criteria not met.

A total of 908 participants were randomized in 1:1:1 ratio to either efpeglenatide 4 milligram (mg), efpeglenatide 6 mg, or dulaglutide 1.5 mg treatment arms, stratified by screening glycated hemoglobin (HbA1c) values (less than \[\<\]8%, greater than or equal to \[\>=\]8 percent \[%\]) and by body mass index (BMI) (\<30 kg/m\^2 and \>=30 kg/m\^2) on Day 1.

Participant milestones

Participant milestones
Measure	Efpeglenatide 4 mg Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Overall Study STARTED	303	302	303
Overall Study Treated	303	302	302
Overall Study Safety Population	313	292	302
Overall Study COMPLETED	200	169	197
Overall Study NOT COMPLETED	103	133	106

Reasons for withdrawal

Reasons for withdrawal
Measure	Efpeglenatide 4 mg Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Overall Study Adverse Event	6	15	11
Overall Study Withdrawal by Subject	35	53	23
Overall Study Lack of Efficacy	0	0	1
Overall Study Poor compliance to protocol	0	4	1
Overall Study Other than specified	62	60	67
Overall Study Randomized and not treated	0	0	1
Overall Study Missing completion status but alive at last contact	0	1	2

Baseline Characteristics

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efpeglenatide 4 mg n=303 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=302 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=303 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.	Total n=908 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 9.6 • n=93 Participants	60.0 years STANDARD_DEVIATION 10.1 • n=4 Participants	59.4 years STANDARD_DEVIATION 10.1 • n=27 Participants	59.9 years STANDARD_DEVIATION 9.9 • n=483 Participants
Sex: Female, Male Female	142 Participants n=93 Participants	157 Participants n=4 Participants	153 Participants n=27 Participants	452 Participants n=483 Participants
Sex: Female, Male Male	161 Participants n=93 Participants	145 Participants n=4 Participants	150 Participants n=27 Participants	456 Participants n=483 Participants
Race/Ethnicity, Customized White	271 Participants n=93 Participants	263 Participants n=4 Participants	275 Participants n=27 Participants	809 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	24 Participants n=93 Participants	30 Participants n=4 Participants	18 Participants n=27 Participants	72 Participants n=483 Participants
Race/Ethnicity, Customized Asian	5 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	14 Participants n=483 Participants
Race/Ethnicity, Customized Other	3 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	9 Participants n=483 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants
Body Mass Index (BMI)	33.4 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.1 • n=93 Participants	33.4 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.2 • n=4 Participants	33.4 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.4 • n=27 Participants	33.4 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.2 • n=483 Participants
Baseline Glycated Hemoglobin (HbA1c %)	8.12 percentage of HbA1c STANDARD_DEVIATION 0.82 • n=93 Participants	8.07 percentage of HbA1c STANDARD_DEVIATION 0.78 • n=4 Participants	8.11 percentage of HbA1c STANDARD_DEVIATION 0.81 • n=27 Participants	8.10 percentage of HbA1c STANDARD_DEVIATION 0.81 • n=483 Participants

PRIMARY outcome

Timeframe: Baseline to Week 56

Population: Analysis was performed on modified intent-to-treat (mITT) population which included participants who completed study treatment; or who discontinued study treatment and completed/discontinued study before early termination; or who discontinued treatment before early termination and discontinued study due to early termination; or who discontinued treatment due to early termination within 30 days of target Week 56 visit.

Outcome measures

Outcome measures
Measure	Efpeglenatide 4 mg n=257 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=254 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=250 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Change From Baseline to Week 56 in HbA1c	-1.12 percentage of HbA1c Standard Error 0.06	-1.17 percentage of HbA1c Standard Error 0.06	-1.09 percentage of HbA1c Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Analysis was performed on mITT population.

Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.

Outcome measures

Outcome measures
Measure	Efpeglenatide 4 mg n=257 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=254 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=250 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Change From Baseline to Week 56 in Body Weight	-2.87 kilogram Standard Error 0.64	-3.04 kilogram Standard Error 0.67	-2.81 kilogram Standard Error 0.66

SECONDARY outcome

Timeframe: Week 56

Population: Analysis was performed on mITT population.

Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Efpeglenatide 4 mg n=257 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=254 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=250 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Number of Participants With HbA1c < 7.0 %	155 Participants	157 Participants	150 Participants

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Analysis was performed on mITT population.

Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.

Outcome measures

Outcome measures
Measure	Efpeglenatide 4 mg n=257 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=254 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=250 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)	-1.81 millimoles per liter (mmol/L) Standard Error 0.15	-1.57 millimoles per liter (mmol/L) Standard Error 0.15	-1.71 millimoles per liter (mmol/L) Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: Analysis was performed on safety population.

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 milligrams per deciliter (mg/dL) (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Outcome measures

Outcome measures
Measure	Efpeglenatide 4 mg n=313 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=292 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=302 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia) Documented symptomatic hypoglycemia (<54 mg/dL)	3 Participants	1 Participants	0 Participants
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia) Severe hypoglycemia	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: Analysis was performed on safety population.

Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 mg/dL (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Outcome measures

Outcome measures
Measure	Efpeglenatide 4 mg n=313 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=292 Participants Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=302 Participants Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year Documented symptomatic hypoglycemia (<54 mg/dL)	0.01 events per participant-year	0.01 events per participant-year	0 events per participant-year
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year Severe hypoglycemia	0 events per participant-year	0 events per participant-year	0 events per participant-year

Adverse Events

Efpeglenatide 4 mg

Serious events: 20 serious events

Other events: 202 other events

Deaths: 0 deaths

Efpeglenatide 6 mg

Serious events: 23 serious events

Other events: 180 other events

Deaths: 0 deaths

Dulaglutide 1.5 mg

Serious events: 20 serious events

Other events: 178 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Efpeglenatide 4 mg n=313 participants at risk Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.	Efpeglenatide 6 mg n=292 participants at risk Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.	Dulaglutide 1.5 mg n=302 participants at risk Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
Infections and infestations Upper Respiratory Tract Infection	6.7% 21/313 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	6.2% 18/292 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	6.6% 20/302 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Metabolism and nutrition disorders Decreased Appetite	12.1% 38/313 • Number of events 39 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	17.1% 50/292 • Number of events 56 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	11.9% 36/302 • Number of events 40 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Nervous system disorders Dizziness	5.8% 18/313 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	3.4% 10/292 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	3.3% 10/302 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain	7.7% 24/313 • Number of events 32 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	10.3% 30/292 • Number of events 39 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	5.3% 16/302 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain Upper	7.0% 22/313 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	5.5% 16/292 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	6.0% 18/302 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Constipation	10.2% 32/313 • Number of events 33 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	11.6% 34/292 • Number of events 37 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	6.3% 19/302 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	29.7% 93/313 • Number of events 128 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	28.4% 83/292 • Number of events 120 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	29.8% 90/302 • Number of events 134 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Dyspepsia	8.3% 26/313 • Number of events 30 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	5.8% 17/292 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	5.0% 15/302 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Nausea	27.2% 85/313 • Number of events 116 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	28.4% 83/292 • Number of events 109 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	25.8% 78/302 • Number of events 111 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	13.1% 41/313 • Number of events 57 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	15.4% 45/292 • Number of events 65 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	12.3% 37/302 • Number of events 64 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.
Investigations Lipase Increased	8.6% 27/313 • Number of events 34 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	6.5% 19/292 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.	7.9% 24/302 • Number of events 29 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60). TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population.

Additional Information

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Email: [email protected]

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