Trial Outcomes & Findings for A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism (NCT NCT03777176)

NCT ID: NCT03777176

Last Updated: 2023-12-13

Results Overview

Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG \<70 mg/dL \[3.9 mmol/L\]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: Baseline, Week 2-4 (Treatment Period 1)
• Results posted on: 2023-12-13

Participant Flow

Participant milestones

Measure	Standard of Care + Dasiglucagon (Treatment Period 1) 4 weeks (Treatment Period 1) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only (Treatment Period 1) 4 weeks (Treatment Period 1) of standard of care only Standard of care: Standard of care according to site and/or country	Standard of Care + Dasiglucagon (Treatment Period 2) 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Treatment Period 1 STARTED	16	16	0
Treatment Period 1 COMPLETED	16	16	0
Treatment Period 1 NOT COMPLETED	0	0	0
Treatment Period 2 STARTED	0	0	32
Treatment Period 2 Completed Study But Discontinued Treatment Due to an AE	0	0	1
Treatment Period 2 COMPLETED	0	0	32
Treatment Period 2 NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Baseline characteristics by cohort

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Total n=32 Participants Total of all reporting groups
Age, Continuous	3.55 years STANDARD_DEVIATION 2.592 • n=5 Participants	5.00 years STANDARD_DEVIATION 2.892 • n=7 Participants	4.27 years STANDARD_DEVIATION 2.800 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Israel	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Germany	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Gastrostomy/nasogastric tube Gastrostomy	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Gastrostomy/nasogastric tube Nasogastric tube	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Gastrostomy/nasogastric tube None	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG <70 mg/dL [3.9 mmol/L]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Hypoglycemia Episode Rate Weekly number of episodes in Weeks 2-4	5.29 episodes per week Standard Deviation 5.256	5.85 episodes per week Standard Deviation 2.767
Hypoglycemia Episode Rate Change from Baseline	-3.05 episodes per week Standard Deviation 4.343	-3.15 episodes per week Standard Deviation 4.753

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: There were 2 missing values at the end of Treatment Period 1 in the dasiglucagon + standard of care group.

Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute continuous glucose monitoring reading <70 mg/dL [3.9 mmol/L]), or the time the test ended if a continuous 15-minute CGM reading <70 mg/dL was not reached. The change from Baseline to the End of Treatment Period 1 (Week 4) is also provided. The Baseline value is the value recorded at the Screening visit.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=14 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Increase in Fasting Tolerance End of Treatment Period 1	6.13 hours Standard Deviation 5.335	4.22 hours Standard Deviation 4.222
Increase in Fasting Tolerance Change from Baseline	1.20 hours Standard Deviation 5.908	1.27 hours Standard Deviation 3.836

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: There was 1 missing value at Baseline for the dasiglucagon + standard of care group.

Percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Weeks 2-4 as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent time in range 70-180 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value was calculated as the average percent time in range during the 14 days before randomization.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Percent Time in Range 70-180 mg/dL Week 2-4	75.10 percent time Standard Deviation 11.821	72.65 percent time Standard Deviation 7.313
Percent Time in Range 70-180 mg/dL Change from Baseline	-0.97 percent time Standard Deviation 11.837	2.44 percent time Standard Deviation 9.584

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Clinically significant hypoglycemia episode rates during Weeks 2-4, defined as average weekly number of clinically significant hypoglycemic episodes (PG <54 mg/dL [3.0 mmol/L]), as detected by SMPG. The Week 2-4 value is the average weekly clinically significant hypoglycemia episode rate across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of clinically significant hypoglycemic episodes during the 2-week baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Clinically Significant Hypoglycemia Episode Rates Weekly number of episodes in Weeks 2-4	1.77 episodes per week Standard Deviation 1.857	1.90 episodes per week Standard Deviation 1.407
Clinically Significant Hypoglycemia Episode Rates Change from Baseline	-0.51 episodes per week Standard Deviation 2.798	-0.35 episodes per week Standard Deviation 1.446

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly.

Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia. The Week 2-4 value is the average weekly total amount of gastric carbohydrates across the last 3 weeks of treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=11 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=13 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia Week 2-4	22.89 grams Standard Deviation 31.415	37.66 grams Standard Deviation 57.998
Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia Change from Baseline	-33.66 grams Standard Deviation 82.767	-19.74 grams Standard Deviation 64.082

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly.

Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 2-4 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=11 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=13 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia Week 2-4	2.30 number of administrations per week Standard Deviation 3.433	2.18 number of administrations per week Standard Deviation 2.714
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia Change from Baseline	-0.29 number of administrations per week Standard Deviation 4.920	-2.13 number of administrations per week Standard Deviation 3.825

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: There was 1 missing value at Baseline for the dasiglucagon + standard of care group.

Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) and below 54 mg/dL [3.0 mmol/L] as measured by continuous glucose monitoring. The extent of hypoglycemia was defined as the AOCglucose under the threshold divided by total duration in hours of CGM measurement. A reduction in this measure indicates a benefit. The Week 2-4 value is the average weekly extent of hypoglycemia below 70 mg/dL and below 54 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Extent of Hypoglycemia Week 2-4: Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L)	0.083 mmol/L Standard Deviation 0.0618	0.147 mmol/L Standard Deviation 0.0736
Extent of Hypoglycemia Change from Baseline in Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L)	-0.062 mmol/L Standard Deviation 0.1003	-0.019 mmol/L Standard Deviation 0.0959
Extent of Hypoglycemia Week 2-4: Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L)	0.015 mmol/L Standard Deviation 0.0117	0.025 mmol/L Standard Deviation 0.0132
Extent of Hypoglycemia Change from Baseline in Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L)	-0.008 mmol/L Standard Deviation 0.0252	-0.007 mmol/L Standard Deviation 0.0252

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly.

Amount of nightly (midnight to 6 am) gastric carbohydrates administered via nasogastric tube or gastrostomy per week. The change from Baseline is also provided for each week. The Baseline value is the value recorded during the 2-week Baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=11 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=13 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Amount of Nightly Gastric Carbohydrates Administered Week 1	95.98 grams Standard Deviation 153.272	33.43 grams Standard Deviation 90.955
Amount of Nightly Gastric Carbohydrates Administered Change from Baseline at Week 1	41.64 grams Standard Deviation 63.484	3.64 grams Standard Deviation 27.29
Amount of Nightly Gastric Carbohydrates Administered Week 2	77.24 grams Standard Deviation 147.065	39.25 grams Standard Deviation 100.638
Amount of Nightly Gastric Carbohydrates Administered Change from Baseline at Week 2	22.90 grams Standard Deviation 137.325	9.46 grams Standard Deviation 40.853
Amount of Nightly Gastric Carbohydrates Administered Week 3	67.59 grams Standard Deviation 141.062	30.31 grams Standard Deviation 94.870
Amount of Nightly Gastric Carbohydrates Administered Change from Baseline at Week 3	13.24 grams Standard Deviation 148.569	0.52 grams Standard Deviation 25.022
Amount of Nightly Gastric Carbohydrates Administered Week 4	63.89 grams Standard Deviation 127.849	34.62 grams Standard Deviation 94.549
Amount of Nightly Gastric Carbohydrates Administered Change from Baseline at Week 4	9.55 grams Standard Deviation 134.369	4.83 grams Standard Deviation 25.689

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly.

Total amount of gastric carbohydrates administered (regardless of whether this was to treat hypoglycemia or not) via nasogastric tube or gastrostomy per week. The Week 2-4 value is the average amount of gastric carbohydrates administered via nasogastric tube or gastrostomy across the last 3 weeks of the treatment period. The change from baseline to Week 2-4 is also provided. The baseline value is the value recorded during the 2-week baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=11 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=13 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Total Amount of Gastric Carbohydrates Administered Week 2-4	567.35 grams Standard Deviation 453.373	775.96 grams Standard Deviation 551.640
Total Amount of Gastric Carbohydrates Administered Change from Baseline	-146.56 grams Standard Deviation 222.995	160.44 grams Standard Deviation 438.735

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: There was 1 missing value at Baseline for the dasiglucagon + standard of care group.

Percent time in hypoglycemia (PG <70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Percent Time in Hypoglycemia Week 2-4	11.77 percent time Standard Deviation 9.248	20.22 percent time Standard Deviation 10.034
Percent Time in Hypoglycemia Change from Baseline	-9.91 percent time Standard Deviation 10.119	-1.95 percent time Standard Deviation 10.186

SECONDARY outcome

Timeframe: Baseline, Week 2-4 (Treatment Period 1)

Population: There was 1 missing value at Baseline for the dasiglucagon + standard of care group.

Rate of hypoglycemic episodes, defined as number of episodes with PG <70 mg/dL (3.9 mmol/L) for 15 minutes or more per week, as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 14 days before randomization.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=16 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only n=16 Participants 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Rate of Hypoglycemic Episodes Week 2-4	21.71 episodes per week Standard Deviation 14.179	36.88 episodes per week Standard Deviation 15.023
Rate of Hypoglycemic Episodes Change from Baseline	-14.37 episodes per week Standard Deviation 21.184	-6.28 episodes per week Standard Deviation 20.565

SECONDARY outcome

Timeframe: Baseline, Week 6-8 (Treatment Period 2)

Population: There was 1 participant with a missing value at Baseline.

Percent time in hypoglycemia (PG <70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. The Week 6-8 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value assessed during the 14 days before randomization.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=32 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Percent Time in Hypoglycemia in Treatment Period 2 Week 6-8	8.64 percent time Standard Deviation 6.011	—
Percent Time in Hypoglycemia in Treatment Period 2 Change from Baseline	-13.27 percent time Standard Deviation 10.120	—

SECONDARY outcome

Timeframe: Baseline, Week 6-8 (Treatment Period 2)

Population: The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly.

Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 6-8 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value recorded during the 2-week Baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=24 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2 Week 6-8	1.31 number of administrations per week Standard Deviation 2.254	—
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2 Change from Baseline	-2.22 number of administrations per week Standard Deviation 4.990	—

SECONDARY outcome

Timeframe: Baseline, Week 6-8 (Treatment Period 2)

Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG <70 mg/dL [3.9 mmol/L]) as detected by SMPG. The Week 6-8 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=32 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Rate of Hypoglycemic Episodes in Treatment Period 2 Weekly number of episodes in Weeks 6-8	3.06 episodes per week Standard Deviation 2.730	—
Rate of Hypoglycemic Episodes in Treatment Period 2 Change from Baseline	-5.61 episodes per week Standard Deviation 4.096	—

SECONDARY outcome

Timeframe: Baseline, Week 6-8 (Treatment Period 2)

Population: There was 1 participant with a missing value at Baseline.

Change from Baseline to Week 6-8 in the clinically significant (CS) hypoglycemia episode rate in treatment period 2, defined as the average weekly number of episodes <54 mg/dL (3.0 mmol/L), for 15 minutes or more, as measured by continuous glucose monitoring (CGM). The Week 6-8 value is the average weekly CS hypoglycemia episode rate across the last 3 weeks of the treatment period. The Baseline value is the average weekly number of CS hypoglycemic episodes during the 14 days before randomization.

Outcome measures

Measure	Standard of Care + Dasiglucagon n=32 Participants 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Standard of Care Only 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2 Week 6-8	7.78 episodes per week Standard Deviation 5.226	—
Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2 Change from Baseline	-8.51 episodes per week Standard Deviation 9.941	—

Adverse Events

Treatment Period 1: Standard of Care + Dasiglucagon

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Treatment Period 1: Standard of Care Only

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment Period 2: Standard of Care + Dasiglucagon

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Period 1: Standard of Care + Dasiglucagon n=16 participants at risk All participants treated with standard of care + dasiglucagon during Treatment Period 1 (Weeks 1 to 4) Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Treatment Period 1: Standard of Care Only n=16 participants at risk All participants treated with standard of care only during Treatment Period 1 (Weeks 1 to 4) Standard of Care: Standard of care according to site and/or country	Treatment Period 2: Standard of Care + Dasiglucagon n=32 participants at risk All participants treated with standard of care + dasiglucagon during Treatment Period 2 (Weeks 5 to 8) Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Infections and infestations Localised Infection	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Vascular Device Infection	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Folliculitis	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations H1N1 Influenza	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).

Other adverse events

Measure	Treatment Period 1: Standard of Care + Dasiglucagon n=16 participants at risk All participants treated with standard of care + dasiglucagon during Treatment Period 1 (Weeks 1 to 4) Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country	Treatment Period 1: Standard of Care Only n=16 participants at risk All participants treated with standard of care only during Treatment Period 1 (Weeks 1 to 4) Standard of Care: Standard of care according to site and/or country	Treatment Period 2: Standard of Care + Dasiglucagon n=32 participants at risk All participants treated with standard of care + dasiglucagon during Treatment Period 2 (Weeks 5 to 8) Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country
Infections and infestations Upper Respiratory Tract Infection	12.5% 2/16 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Localised Infection	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Folliculitis	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Candida Nappy Rash	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Ear Infection	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Gastritis Viral	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Herpangina	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Hordeolum	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Influenza	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Viral Upper Respiratory Tract Infection	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Nasopharyngitis	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Gastroenteritis Viral	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Hand-Foot-And-Mouth Disease	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Eczema Infected	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	9.4% 3/32 • Number of events 3 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Periorbital Cellulitis	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Pharyngitis Streptococcal	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Eczema	31.2% 5/16 • Number of events 5 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Rash	18.8% 3/16 • Number of events 4 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Rash Maculo-Papular	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Dermatitis	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Erythema	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Miliaria	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Urticaria	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Dermatitis Diaper	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Necrolytic Migratory Erythema	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Pruritus Generalised	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Skin and subcutaneous tissue disorders Skin Discolouration	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Vomiting	31.2% 5/16 • Number of events 7 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 5 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Teething	12.5% 2/16 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Constipation	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Post-Tussive Vomiting	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Gastrointestinal disorders Retching	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Nervous system disorders Headache	6.2% 1/16 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Nervous system disorders Drooling	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Nervous system disorders Seizure	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Nervous system disorders Loss Of Consciousness	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
General disorders Medical Device Site Irritation	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
General disorders Pyrexia	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
General disorders Catheter Site Haemorrhage	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
General disorders Developmental Delay	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
General disorders Infusion Site Bruising	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Hepatic Enzyme Increased	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Aspartate Aminotransferase Increased	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Alanine Aminotransferase Increased	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Blood Glucose Increased	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Blood Iron Decreased	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Glycosylated Haemoglobin Increased	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Investigations Weight Decreased	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Blood and lymphatic system disorders Anaemia	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Eye disorders Eye Movement Disorder	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Psychiatric disorders Irritability	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	12.5% 4/32 • Number of events 16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Metabolism and nutrition disorders Ketosis	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Metabolism and nutrition disorders Increased Appetite	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Ear and labyrinth disorders Otorrhoea	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 1/16 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/32 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Ear and labyrinth disorders Ear Pain	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Injury, poisoning and procedural complications Contusion	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	6.2% 2/32 • Number of events 2 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Injury, poisoning and procedural complications Stoma Site Hypergranulation	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Cardiac disorders Pericardial Effusion	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Musculoskeletal and connective tissue disorders Muscle Twitching	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
Vascular disorders Aortic Dilatation	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	0.00% 0/16 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).	3.1% 1/32 • Number of events 1 • Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).

Additional Information

Sune Birch

Zealand Pharma

Phone: +45 5060 3864

Email: SBirch@zealandpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place