SHERRY

CompletedPhase 2

Treatment of Post-bariatric Hypoglycaemia

Ready-to-use Dasiglucagon for the Treatment of Postprandial Hypoglycaemia in Roux-en-Y Gastric Bypass Operated Patients

Lead sponsor

Filip Krag Knop

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance

Eligibility highlights

Primary endpoint

•Time spent in hypoglycaemia (IG < 3.9 mmol)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04836273

Org study IDCKN-DASI120-RYGB

Secondary ID2020-005241-16

Timeline

Milestones

Study first posted2021-04-08actual

Study start2021-08-20actual

Primary completion2022-05-15actual

Study completion2022-12-15actual

Last update posted2023-02-02actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Documented postprandial hypoglycaemia (IG <3.9 mmol/l, ≥3 times/week) assessed by 14-days of blinded CGM recording

•Haemoglobin levels for women >7.3 mmol/l and for men >8.3 mmol/l

•Ferritin >10 μg/l

•Cobalamin >150 pmol/l

•Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l

•Normal electrocardiogram (ECG)

•Negative urine human chorionic gonadotropin (hCG) (for fertile women)

Exclusion criteria

•Treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs

•Treatment with antipsychotics

•Current participation in another clinical trial with administration of investigational drug

•Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening

•History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis)

•Pregnancy

•Breastfeeding

•Major surgery within 30 days before screening

•Alcohol abuse (per investigator assessment)

•Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial

•History of pheochromocytoma or insulinoma

•History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients

•Known or suspected allergies to glucagon or related products

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Glycaemic time in range defined as: 1) hypoglycaemia (<3.9 mmol/l), 2) normoglycaemia (3.9-10.0 mmol/l), and 3) hyperglycaemia (>10.0 mmol/l)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

descriptive

Secondary/protocol endpoint

Glycaemic variability assessed as coefficient of variance (CV)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

descriptive

Secondary/protocol endpoint

Glycaemic variability assessed as standard deviation (SD)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

descriptive

Secondary/protocol endpoint

Nadir plasma glucose as assessed both as 1) absolute lowest value, and 2) a mean of three consecutive glucose measurements during the 240-minute MMT

Time frame:Two hundred forty minutes of mixed meal test

concentration, descriptive

Secondary/protocol endpoint

Glycaemic rescue intervention due to critically low plasma glucose concentration (<1.8 mmol/l)

Time frame:Two hundred forty minutes of mixed meal test

concentration, descriptive

Secondary/protocol endpoint

Peak plasma glucose concentration after study drug administration

Time frame:Two hundred forty minutes of mixed meal test

concentration, descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Changes in blood pressure

Time frame:Two hundred forty minutes of mixed meal test

descriptive

Secondary/protocol endpoint

Changes in heart rate

Time frame:Two hundred forty minutes of mixed meal test

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in QoL as assessed by the World Health Organization's quality of life assessment (WHOQOL-BREF)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Time spent in hypoglycaemia (IG < 3.9 mmol)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

descriptive

Secondary/protocol endpoint

Time (percent or minutes) spent in serious hypoglycaemia (IG <3.0 mmol/l)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

descriptive

Secondary/protocol endpoint

Frequency of hypoglycaemic events (IG <3.9 mmol/l and <3.0 mmol/l, respectively)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

event count, event

Secondary/protocol endpoint

Change in hypoglycaemic symptoms will be evaluated by Edinburgh Hypoglycaemia Symptom Scale (EHSS)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

change from baseline, event

Secondary/protocol endpoint

Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale (HFS-II)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

change from baseline, event

Secondary/protocol endpoint

Time spent in level 1 and level 2 hypoglycaemia (<3.9 and <3.0 mmol/l, respectively) from study drug administration until 240 minutes

Time frame:Two hundred forty minutes of mixed meal test

ratio, event

Secondary/protocol endpoint

Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s from signed consent form to end of study (visit 4 / follow-up visit)

Time frame:Through study completion which is an average of 16 weeks

descriptive

Secondary/protocol endpoint

Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s during the in-patient part MMTs

Time frame:During the in-patient part (MMTs) 0-240 minutes / Two hundred forty minutes of mixed meal test

descriptive

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Frequency of hyperglycaemic events (IG >7.8 mmol/l and >10.0 mmol/l, respectively)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

event count, event

Secondary/protocol endpoint/low confidence

Recovery of BG 15 minutes after trial drug administration (as measured by finger prick (BG >3.9 mmol/l))

Time frame:During the four weeks of placebo and dasiglucagon treatment.

ratio, improvement

Secondary/protocol endpoint/low confidence

Change in administration frequency (as measured by percentage)

Time frame:During the four weeks of placebo and dasiglucagon treatment.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l))

Time frame:Two hundred forty minutes of mixed meal test

ratio, improvement

Secondary/protocol endpoint/low confidence

Time spent in hyperglycaemia (>7.8 mmol/l) from study drug administration until 240 minutes

Time frame:Two hundred forty minutes of mixed meal test

ratio, improvement

Secondary/protocol endpoint/low confidence

Counter-regulatory hormonal response

Time frame:Two hundred forty minutes of mixed meal test

descriptive

Secondary/protocol endpoint/low confidence

Percentage (%) of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies who did not have anti-dasiglucagon antibodies at baseline

Time frame:Through study completion which is an average of 16 weeks

descriptive

Secondary/protocol endpoint/low confidence

Device failures/ malfunctions occurring during the trial.

Time frame:Through study completion which is an average of 16 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.