Trial Outcomes & Findings for Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea (NCT NCT03770728)

NCT ID: NCT03770728

Last Updated: 2021-12-02

Results Overview

This analysis included all Week 30 assessment values available.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

312 participants

Primary outcome timeframe

Baseline to Week 30

Results posted on

2021-12-02

Participant Flow

The study was conducted at 48 active sites in 3 countries. A total of 560 participants were screened between 01 August 2019 and 09 August 2020, out of which 248 were screen failures. Screen failures were mainly due to inclusion criteria not met.

A total of 312 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 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Overall Study STARTED	79	78	77	78
Overall Study Safety Population	79	78	80	75
Overall Study COMPLETED	41	47	45	43
Overall Study NOT COMPLETED	38	31	32	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Overall Study Adverse Event	1	0	1	0
Overall Study Poor compliance to protocol	0	0	1	0
Overall Study Withdrawal by Subject	13	8	9	13
Overall Study Other than specified	24	23	21	22

Baseline Characteristics

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=79 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=78 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=77 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=78 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.	Total n=312 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	60.1 years STANDARD_DEVIATION 10.9 • n=7 Participants	57.9 years STANDARD_DEVIATION 10.5 • n=5 Participants	58.8 years STANDARD_DEVIATION 11.5 • n=4 Participants	58.9 years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	39 Participants n=4 Participants	140 Participants n=21 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants	39 Participants n=4 Participants	172 Participants n=21 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	43 Participants n=7 Participants	46 Participants n=5 Participants	48 Participants n=4 Participants	179 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants
Race/Ethnicity, Customized Asian	24 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	22 Participants n=4 Participants	96 Participants n=21 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Baseline Glycated Hemoglobin (HbA1c %)	8.09 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=5 Participants	8.07 percentage of HbA1c STANDARD_DEVIATION 0.76 • n=7 Participants	8.15 percentage of HbA1c STANDARD_DEVIATION 0.69 • n=5 Participants	8.09 percentage of HbA1c STANDARD_DEVIATION 0.79 • n=4 Participants	8.10 percentage of HbA1c STANDARD_DEVIATION 0.76 • n=21 Participants
Body Mass Index (BMI)	32.2 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.1 • n=5 Participants	31.8 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.7 • n=7 Participants	32.0 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.3 • n=5 Participants	32.4 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.4 • n=4 Participants	32.1 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 7.1 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 30

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

This analysis included all Week 30 assessment values available.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=48 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=49 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=48 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Change From Baseline to Week 30 in HbA1c	-0.27 percentage of HbA1c Standard Deviation 0.92	-1.05 percentage of HbA1c Standard Deviation 0.88	-1.46 percentage of HbA1c Standard Deviation 0.90	-1.36 percentage of HbA1c Standard Deviation 1.09

SECONDARY outcome

Timeframe: Week 30

Population: Analysis was performed on ITT population.

Participants who had no available assessment for HbA1c \<7% at Week 30 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=78 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=77 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=78 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Number of Participants With HbA1c <7.0%	11 Participants	27 Participants	33 Participants	32 Participants

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.

This analysis included all Week 30 assessment values available.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=45 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=47 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=43 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)	0.12 millimoles per liter (mmol/L) Standard Deviation 2.37	-0.97 millimoles per liter (mmol/L) Standard Deviation 2.43	-1.75 millimoles per liter (mmol/L) Standard Deviation 2.43	-1.20 millimoles per liter (mmol/L) Standard Deviation 4.68

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.

This analysis included all Week 30 assessment values available.

Outcome measures

Outcome measures
Measure	Placebo n=47 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=46 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=47 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=47 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Change From Baseline to Week 30 in Body Weight	-1.89 kilograms Standard Deviation 5.53	-2.49 kilograms Standard Deviation 3.93	-2.72 kilograms Standard Deviation 6.49	-3.87 kilograms Standard Deviation 4.62

SECONDARY outcome

Timeframe: Baseline up to Week 30

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	Placebo n=79 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=78 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=80 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=75 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
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)	1 Participants	0 Participants	2 Participants	3 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	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 30

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=79 Participants Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=78 Participants Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=80 Participants Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=75 Participants Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
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)	0.03 events per participant-year	0 events per participant-year	0.06 events per participant-year	0.14 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	0 events per participant-year

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Efpeglenatide 2 mg

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Efpeglenatide 4 mg

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Efpeglenatide 6 mg

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=79 participants at risk Participants received placebo (matched to Efpeglenatide) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 2 mg n=78 participants at risk Participants received Efpeglenatide 2 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.	Efpeglenatide 4 mg n=80 participants at risk Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.	Efpeglenatide 6 mg n=75 participants at risk Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
Infections and infestations Nasopharyngitis	1.3% 1/79 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	3.8% 3/78 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	1.2% 1/80 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	6.7% 5/75 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	11.4% 9/79 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	6.4% 5/78 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	2.5% 2/80 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	6.7% 5/75 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Infections and infestations Urinary Tract Infection	0.00% 0/79 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	3.8% 3/78 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	7.5% 6/80 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	2.7% 2/75 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/79 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	2.6% 2/78 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	5.0% 4/80 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	5.3% 4/75 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain	0.00% 0/79 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	0.00% 0/78 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	1.2% 1/80 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	5.3% 4/75 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	5.1% 4/79 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	10.3% 8/78 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	16.2% 13/80 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	16.0% 12/75 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Nausea	6.3% 5/79 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	12.8% 10/78 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	20.0% 16/80 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	10.7% 8/75 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	1.3% 1/79 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	6.4% 5/78 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	7.5% 6/80 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	13.3% 10/75 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
General disorders Fatigue	1.3% 1/79 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	5.1% 4/78 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	6.2% 5/80 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	0.00% 0/75 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
General disorders Injection Site Pain	5.1% 4/79 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	2.6% 2/78 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	2.5% 2/80 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	2.7% 2/75 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.
Investigations Lipase Increased	1.3% 1/79 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	5.1% 4/78 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	7.5% 6/80 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. Analysis was performed on safety population.	4.0% 3/75 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent up to end of study (up to Week 36). 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 34). TEAEs were defined as AEs that developed or worsened or became serious during the treatment-emergent period. 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.
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Restriction type: OTHER