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CompletedPhase 1

Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

A Randomized, Double-blind, Placebo-controlled, Doseescalation Trial to Evaluate the Safety and Tolerability of a Single IV Administration of Dasiglucagon and the Bioavailability of Dasiglucagon Following SC Compared to IV Administration in Healthy Subjects

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

60

Study population

Prediabetes / glucose intolerance

Eligibility highlights

•Healthy volunteers

Primary endpoint

•Treatment-related adverse events

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 IDNCT03735225
Org study IDZP4207-17144

Timeline

Milestones

Study start2018-11-07actual
Study first posted2018-11-08actual
Primary completion2019-06-24actual
Study completion2019-06-24actual
Last update posted2021-03-23actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject).
•Healthy female or male subjects aged between 18 and 45 years, both inclusive.
•Body weight between 60 and 90 kg, both inclusive.
•Subjects in good health according to age (medical history, physical examination, vital signs, and laboratory assessments), as judged by the investigator.
•Systolic Blood Pressure (SBP) ≥90 mmHg, ≤140 mmHg and Diastolic Blood Pressure (DBP) ≤90 mmHg measured after at least 5 min rest in supine position.
•A pulse rate of ≥50 and ≤90 b/min measured after at least 5 min rest in supine position.
•12-lead ECG with QTcF < 450 ms, PR < 220 ms and QRS < 110 ms.
•A female subject must meet one of the following criteria:
-Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until the last follow-up visit. An acceptable method of contraception includes one of the following:
-Total heterosexual sexual abstinence can be used as a method of contraception if this is the participant's preferred lifestyle and the method is established. Periodic sexual abstinence is not an acceptable method of contraception

Single method (use only one method):

•intrauterine device (IUD),
•hormone rod inserted under the skin,
•male partner's sterilization

Double method:

•Hormone contraception A) estrogen and / or progesterone oral contraceptives, B) transdermal patch, C) vaginal ring, D) injection in combination with one of the following:
a)vaginal cap with spermicide,
b)vaginal sponge (only for women who have never given birth),
c)condom,
d)female condom
•Participant is of non-childbearing potential, if she is either surgically sterilized (ie, by tubal ligation or removal of ovaries), has undergone complete hysterectomy, or is in a menopausal state (i.e., at least one year without menses).
-A male subject who is sexually active and has a female partner who is of childbearing potential, must use a condom throughout the entire duration of the trial from screening and until the last follow-up visit.

Condoms MUST be combined with one of the following methods:

•IUD,
•hormone rod inserted under the skin,
•vaginal cap with spermicide,
•vaginal sponge (only for women who have never given birth),
•hormone contraception A) estrogen and / or progesterone oral contraceptives, B) transdermal patch, C) vaginal ring or D) injection
-Total heterosexual sexual abstinence can be used as a method of contraception if this is the participant's preferred lifestyle and the method is established. Periodic sexual abstinence is not an acceptable method of contraception.

Exclusion criteria

•Previous participation in any trial with dasiglucagon. Participation defined as enrolled into trial.
•Known or suspected hypersensitivity to trial product(s) or related products.
•History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction.
•Receipt of any investigational product within 3 months prior to screening.
•Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.
•Any history or presence of cancer, except adequately treated (as judged by investigator) basal or squamous cell skin cancer or cervical carcinoma in situ.
•A history or presence of any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological or psychiatric diseases, or other major diseases at the discretion of the investigator.
•Known cardiovascular disease, arthrosclerosis, angina pectoris, or a history of myocardial infarction or coronary arterial bypass graft/percutaneous coronary intervention.
•Clinically significant illness (eg, systemic infection) within 4 weeks before screening, as judged by the investigator.
•Any significant pre-existing medical condition as well as pre-planned procedures or surgeries.
•Positive results for Hepatitis B antigens, Hepatitis C antibodies and/or human immunodeficiency virus (HIV) 1 antigen or HIV1/2 antibodies, at screening.
•Any clinically significant abnormal hematology, biochemistry, or urinalysis screening tests, as judged by the investigator.
•Any of the following abnormal laboratory parameters at screening:
-alanine aminotransferase (ALT) > upper limit of normal [ULN] + 10%, aspartate aminotransferase (AST) > ULN + 10%,
-Bilirubin > ULN + 20%
•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR <90 ml/min/1.73 m2 as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 (14).
•Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine position at screening, as evaluated by the investigator.
•Donation of blood or blood loss of more than 500 mL within 12 weeks prior to screening.
•The use of any non-prescribed systemic medication, except routine vitamins and occasional use of acetylsalicylic acid and paracetamol within 14 days prior to randomization.
•A positive result in the alcohol and/or urine drug screen at the screening visit.
•A history of alcoholism or drug abuse as judged by the investigator
•Smokers (defined as a subject who has been smoking within the last 6 month).
•Subjects with mental incapacity or language barriers that preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial.

Endpoints (10)

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
8
Cardiometabolic biomarkers
2

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change-from-baseline in ECG for heart rate (HR)

Time frame:From day -1 to day 2 and day 28

descriptive

Secondary/protocol endpoint

Change-from-baseline in ECG for pulse rate (PR)

Time frame:From day -1 to day 2 and day 28

descriptive

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame:day 1, day 2, day 28

event count, event

Secondary/protocol endpoint

Clinical assessment of local tolerability at injection site by physical examination

Time frame:day-1, day 1, day 2, day 28

descriptive

Secondary/protocol endpoint

Occurrence of anti-drug antibodies (ADA)

Time frame:day 1 and day 28

descriptive

Secondary/protocol endpoint

Plasma dasiglucagon profiles following IV administration, Area Under the Curve (AUC)

Time frame:Pre-dose, 5, 15, 25, 40, 60, 80, 100, 120, 140, 180 and 240 min.

concentration, descriptive

Secondary/protocol endpoint

Plasma dasiglucagon profiles following SC administration, Area Under the Curve (AUC)

Time frame:Pre-dose, 5, 15, 25, 35, 45, 60, 90, 130, 210 and 300 min.

concentration, descriptive

Secondary/protocol endpoint

Change-from-baseline in ECG for QTcF

Time frame:From day -1 to day 2 and day 28

descriptive

Secondary/protocol endpoint

Change-from-baseline in ECG for QRS

Time frame:From day -1 to day 2 and day 28

descriptive

Secondary/protocol endpoint

Frequency of treatment-emergent T-wave morphology changes and U-waves by Holter monitoring

Time frame:From day -1 to day 2

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.