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Type 1 DiabetesPhase 1NCT05007977

Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus

A Phase 1 study testing ZT-01 low dose and ZT-01 high dose in people with Type 1 Diabetes and Hypoglycemia, run by Zucara Therapeutics Inc. at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes, Hypoglycemia
What is being tested?
ZT-01 low dose and ZT-01 high dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
8 Jul 2021to 18 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 1 diabetes for at least 5 years and receiving insulin as the only T1D therapy
  • HbA1c ≥6.0 and ≤9.0 %
  • BMI ≥18 to ≤27 kg/m^2
  • Normal thyroid function

Who cannot join

  • Impaired hypoglycemia awareness
  • Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months
  • Abnormal blood pressure or ECG, clinically significant cardiovascular, cerebrovascular or peripheral vascular disease
  • History of pheochromocytoma, insulinoma, glucagonoma, acromegaly, Cushing's disease, glycogen storage disease or adrenal insufficiency; ongoing or previous treatment with octreotide, lanreotide or pasireotide
  • Current use of systemic corticosteroids or beta-blockers

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • LMC Manna Research

    Toronto, Ontario, M4G 3E8

Other trials in Canada

About this study

Official title: Pharmacodynamic Evaluation of ZT-01 in a Stepped Hypoglycemic Clamp Model in Subjects With Type 1 Diabetes Mellitus

The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia.

Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp.

Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.

Being tested
ZT-01 low dose, ZT-01 high dose, Placebo
Keywords
hypoglycemic clamp, glucagon counterregulation
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZT-01 low doseDrug

    Single subcutaneous (SC) injection of ZT-01 3 mg during hypoglycemic clamp

  • ZT-01 high doseDrug

    Single SC injection of ZT-01 20 mg during hypoglycemic clamp

  • PlaceboDrug

    Single SC injection of placebo during hypoglycemic clamp

Study groups in NCT05007977
Study groupRoleWhat they receive
Treatment order: placebo, low dose, high doseExperimentalSubjects will receive a single administration of each treatment in this order during three consecutive clamps
Receives: Drug: ZT-01 low dose; Drug: ZT-01 high dose; Drug: Placebo
Treatment order: placebo, high dose, low doseExperimentalSubjects will receive a single administration of each treatment in this order during three consecutive clamps
Receives: Drug: ZT-01 low dose; Drug: ZT-01 high dose; Drug: Placebo
Treatment order: low dose, placebo, high doseExperimentalSubjects will receive a single administration of each treatment in this order during three consecutive clamps
Receives: Drug: ZT-01 low dose; Drug: ZT-01 high dose; Drug: Placebo
Treatment order: low dose, high dose, placeboExperimentalSubjects will receive a single administration of each treatment in this order during three consecutive clamps
Receives: Drug: ZT-01 low dose; Drug: ZT-01 high dose; Drug: Placebo
Treatment order: high dose, placebo, low doseExperimentalSubjects will receive a single administration of each treatment in this order during three consecutive clamps
Receives: Drug: ZT-01 low dose; Drug: ZT-01 high dose; Drug: Placebo
Treatment order: high dose, low dose, placeboExperimentalSubjects will receive a single administration of each treatment in this order during three consecutive clamps
Receives: Drug: ZT-01 low dose; Drug: ZT-01 high dose; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glucagon between euglycemia and hypoglycemia

    Mean and peak glucagon level during euglycemia and each hypoglycemic period of the clamp

    Measured: During each clamp, up to 12 weeks

Secondary outcomes (5)

  1. Insulin infused

    Insulin administered during euglycemia and each hypoglycemic period of the clamp

    Measured: During each clamp, up to 12 weeks

  2. Insulin infusion rate

    Rate of insulin administered during euglycemia and each hypoglycemic period of the clamp

    Measured: During each clamp, up to 12 weeks

  3. Change in catecholamines between euglycemia and hypoglycemia

    Epinephrine and norepinephrine during euglycemia and each stable hypoglycemic period of the clamp

    Measured: During each clamp, up to 12 weeks

  4. Change in growth hormone between euglycemia and hypoglycemia

    Growth hormone during euglycemia and each stable hypoglycemic period

    Measured: During each clamp, up to 12 weeks

  5. Change in cortisol between euglycemia and hypoglycemia

    Cortisol during euglycemia and each stable hypoglycemic period

    Measured: During each clamp, up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start8 Jul 2021
  3. Primary completion12 Apr 2022
  4. Study completion18 Apr 2022

Why it stopped: The study was completed following review of the assumptions underlying the power calculation and it was deemed that enough subjects had been recruited to complete enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Subjects will be randomized to the order in which they receive three treatments during consecutive clamps
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007977
Sponsor's protocol ID
ZT01-CL-1003
Status last verified
Jul 2023
First submitted
20 Jul 2021
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abitbol A, Riddell MC, Peers S, Simonson E, Evans M, Knop FK, Liggins RT. Effect of somatostatin receptor 2 antagonism on glucagon counterregulation during a hyperinsulinaemic euglycaemic-hypoglycaemic glucose clamp in adult men and women with long-standing type 1 diabetes: a randomised crossover phase 1 study. Diabetologia. 2026 Aug;69(8):2143-2154. doi: 10.1007/s00125-026-06748-9. Epub 2026 May 21.

    PubMed 42168649

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZT-01 low dose and ZT-01 high dose in people with Type 1 Diabetes and Hypoglycemia, run by Zucara Therapeutics Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was completed following review of the assumptions underlying the power calculation and it was deemed that enough subjects had been recruited to complete enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glucagon between euglycemia and hypoglycemia (time frame: During each clamp, up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007977, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.

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