Trial Outcomes & Findings for Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s) (NCT NCT03713684)

NCT ID: NCT03713684

Last Updated: 2021-12-02

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

370 participants

Primary outcome timeframe

Baseline to Week 30

Results posted on

2021-12-02

Participant Flow

The study was conducted at 47 active sites in 3 countries. A total of 540 participants were screened between 09 November 2018 and 02 September 2020, out of which 170 were screen failures. Screen failures were mainly due to inclusion criteria not met.

A total of 370 participants were randomized in 1:1:1:1 ratio to either placebo, efpeglenatide 2 milligrams (mg), efpeglenatide 4 mg, or efpeglenatide 6 mg treatment arms, stratified by screening glycated hemoglobin (HbA1c) values (less than \[\<\]8%, greater than or equal to \[\>=\]8%) and sulfonylurea (SU) use at screening (Yes/No).

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).	Efpeglenatide 2 mg Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Overall Study STARTED	92	92	93	93
Overall Study Safety Population	92	92	96	90
Overall Study Completed 30-Week Core Treatment Period	50	52	51	49
Overall Study COMPLETED	6	5	5	6
Overall Study NOT COMPLETED	86	87	88	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).	Efpeglenatide 2 mg Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Overall Study Adverse Event	1	3	1	0
Overall Study Poor compliance to protocol	2	1	0	1
Overall Study Withdrawal by Subject	14	6	14	16
Overall Study Other than specified	69	77	73	70

Baseline Characteristics

Here, 'number analyzed' = participants with available data for the specified baseline measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=92 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=92 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=93 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=93 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.	Total n=370 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 10.7 • n=92 Participants	59.1 years STANDARD_DEVIATION 10.7 • n=92 Participants	60.6 years STANDARD_DEVIATION 11.5 • n=93 Participants	61.6 years STANDARD_DEVIATION 10.3 • n=93 Participants	60.1 years STANDARD_DEVIATION 10.8 • n=370 Participants
Sex: Female, Male Female	49 Participants n=92 Participants	42 Participants n=92 Participants	42 Participants n=93 Participants	40 Participants n=93 Participants	173 Participants n=370 Participants
Sex: Female, Male Male	43 Participants n=92 Participants	50 Participants n=92 Participants	51 Participants n=93 Participants	53 Participants n=93 Participants	197 Participants n=370 Participants
Race/Ethnicity, Customized White	45 Participants n=92 Participants	49 Participants n=92 Participants	51 Participants n=93 Participants	50 Participants n=93 Participants	195 Participants n=370 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=92 Participants	9 Participants n=92 Participants	10 Participants n=93 Participants	8 Participants n=93 Participants	36 Participants n=370 Participants
Race/Ethnicity, Customized Asian	36 Participants n=92 Participants	33 Participants n=92 Participants	30 Participants n=93 Participants	34 Participants n=93 Participants	133 Participants n=370 Participants
Race/Ethnicity, Customized Other	2 Participants n=92 Participants	1 Participants n=92 Participants	1 Participants n=93 Participants	1 Participants n=93 Participants	5 Participants n=370 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=92 Participants	0 Participants n=92 Participants	1 Participants n=93 Participants	0 Participants n=93 Participants	1 Participants n=370 Participants
Baseline Glycated Hemoglobin (HbA1c %)	8.54 percentage of HbA1c STANDARD_DEVIATION 0.83 • n=92 Participants	8.42 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=92 Participants	8.46 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=93 Participants	8.40 percentage of HbA1c STANDARD_DEVIATION 0.72 • n=93 Participants	8.46 percentage of HbA1c STANDARD_DEVIATION 0.78 • n=370 Participants
Body Mass Index (BMI)	30.1 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.6 • n=91 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	31.1 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.1 • n=92 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	30.0 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.6 • n=93 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	31.0 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.1 • n=93 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	30.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.4 • n=369 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.

PRIMARY outcome

Timeframe: Baseline to Week 30

Population: Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization. Here, "Overall number of participants analyzed"= participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=63 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=60 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=63 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Change From Baseline to Week 30 in HbA1c	-0.33 percentage of HbA1c Standard Deviation 1.09	-1.27 percentage of HbA1c Standard Deviation 0.95	-1.24 percentage of HbA1c Standard Deviation 0.96	-1.43 percentage of HbA1c Standard Deviation 0.94

SECONDARY outcome

Timeframe: Week 30

Population: Analysis was performed on ITT population.

Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=92 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=93 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=93 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Number of Participants With HbA1c <7.0% at Week 30	10 Participants	32 Participants	28 Participants	40 Participants

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Analysis was performed on ITT population. Here, "Overall number of participants analyzed"= participants evaluable for this outcome measure.

This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=8 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=10 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=14 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Change From Baseline to Week 56 in HbA1c	-0.32 percentage of HbA1c Standard Deviation 0.86	-1.08 percentage of HbA1c Standard Deviation 0.77	-1.23 percentage of HbA1c Standard Deviation 0.88	-1.16 percentage of HbA1c Standard Deviation 1.34

SECONDARY outcome

Timeframe: Baseline to Week 30

Population: Analysis was performed on ITT population. Here, "Overall number of participants analyzed"= participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=55 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=51 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=56 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)	-0.41 millimoles per liter (mmol/L) Standard Deviation 3.00	-1.34 millimoles per liter (mmol/L) Standard Deviation 2.80	-1.33 millimoles per liter (mmol/L) Standard Deviation 3.52	-2.22 millimoles per liter (mmol/L) Standard Deviation 1.89

SECONDARY outcome

Timeframe: Baseline to Week 30 and Week 56

Population: Analysis was performed on ITT population. Here, "Overall number of participants analyzed"= participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified row.

This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=64 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=61 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=62 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Change From Baseline to Week 30 and Week 56 in Body Weight Week 30	0.29 kilograms Standard Deviation 3.23	-0.68 kilograms Standard Deviation 3.63	-1.99 kilograms Standard Deviation 3.13	-3.14 kilograms Standard Deviation 3.19
Change From Baseline to Week 30 and Week 56 in Body Weight Week 56	0.66 kilograms Standard Deviation 3.22	-2.39 kilograms Standard Deviation 10.69	-1.77 kilograms Standard Deviation 5.36	-2.85 kilograms Standard Deviation 4.80

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	Placebo n=92 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=92 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=96 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=90 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia) Documented symptomatic hypoglycemia (<54 mg/dL)	4 Participants	8 Participants	10 Participants	9 Participants
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia) Severe hypoglycemia	1 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 56

Population: Analysis was performed on safety population.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=92 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=96 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=90 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year Severe hypoglycemia	0.09 events per participant-year	0.05 events per participant-year	0.05 events per participant-year	0.04 events per participant-year
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)	0.07 events per participant-year	0.27 events per participant-year	0.45 events per participant-year	0.46 events per participant-year

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 25 other events

Deaths: 0 deaths

Efpeglenatide 2 mg

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

Efpeglenatide 4 mg

Serious events: 5 serious events

Other events: 42 other events

Deaths: 0 deaths

Efpeglenatide 6 mg

Serious events: 10 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=92 participants at risk Participants received placebo (matched to efpeglenatide) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 2 mg n=92 participants at risk Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.	Efpeglenatide 4 mg n=96 participants at risk Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.	Efpeglenatide 6 mg n=90 participants at risk Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
Infections and infestations Upper Respiratory Tract Infection	5.4% 5/92 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	4.3% 4/92 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	4.2% 4/96 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	5.6% 5/90 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Metabolism and nutrition disorders Decreased Appetite	1.1% 1/92 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	2.2% 2/92 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	11.5% 11/96 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	14.4% 13/90 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Distension	0.00% 0/92 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	3.3% 3/92 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	3.1% 3/96 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	5.6% 5/90 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain	1.1% 1/92 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	4.3% 4/92 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	6.2% 6/96 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	3.3% 3/90 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Constipation	3.3% 3/92 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	5.4% 5/92 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	5.2% 5/96 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	15.6% 14/90 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	7.6% 7/92 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	10.9% 10/92 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	15.6% 15/96 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	15.6% 14/90 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	1.1% 1/92 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	3.3% 3/92 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	3.1% 3/96 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	10.0% 9/90 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Nausea	6.5% 6/92 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	15.2% 14/92 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	19.8% 19/96 • Number of events 21 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	17.8% 16/90 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	4.3% 4/92 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	4.3% 4/92 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	12.5% 12/96 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	10.0% 9/90 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
General disorders Fatigue	3.3% 3/92 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	1.1% 1/92 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	1.0% 1/96 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	5.6% 5/90 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Investigations Amylase Increased	0.00% 0/92 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	6.5% 6/92 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	0.00% 0/96 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	2.2% 2/90 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.
Investigations Lipase Increased	2.2% 2/92 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	9.8% 9/92 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	4.2% 4/96 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.	8.9% 8/90 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 62). Time frame for reporting of treatment emergent adverse events (TEAEs) was from first injection of Investigational Medicinal Product (IMP) up to 30 days after the last injection of the IMP (i.e. up to Week 60). TEAEs were defined as AEs that developed or worsened, or became serious during the treatment-emergent period (time from first injection of IMP up to 30 days after the last injection of the IMP \[i.e. up to Week 60\]). Analysis was performed on safety population.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Publication restrictions are in place

Restriction type: OTHER