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Join a Clinical Trial Investigating a New Medication to Prevent Nighttime Lows

Published: 4/8/24 2:55 pm
By April Hopcroft

Zucara Clinical Trial for ZT-01 Diabetes DrugThe study is investigating whether an injectable drug, ZT-01, could prevent nighttime hypoglycemia in people with type 1 diabetes. Participate and shape the future of diabetes care.

Clinical Trials Identifier: NCT05762107

Trial Name: A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes (ZONE)

Diabetes Type: Adults with type 1 diabetes

Trial Sponsor: Zucara Therapeutics

What is the trial researching?

This study will assess how an investigational medication called ZT-01 affects low blood sugar in adults with type 1 diabetes who are prone to nighttime hypoglycemia. The trial aims to address two key questions:

  1. Does ZT-01 lower the number of nighttime hypoglycemia events?

  2. How does ZT-01 affect blood sugar levels?

Participants will self-inject ZT-01 before bed and will be monitored for hypoglycemia using their own continuous glucose monitor (CGM) or a study-provided CGM. The study will last about eight to 16 weeks.

How does ZT-01 work?

ZT-01 works by increasing the amount of glucagon – a hormone produced naturally in the body when blood sugars drop – that is made during hypoglycemia. People with diabetes use synthetic glucagon to raise blood sugars during hypoglycemia.

More specifically, as a somatostatin receptor 2 antagonist, ZT-01 prevents the release of somatostatin, a hormone that inhibits glucagon release. In this way, ZT-01 acts to increase the amount of glucagon produced by the body during hypoglycemia.

In a small proof-of-concept trial, 90% of participants saw increased glucagon levels after ZT-01 treatment, with no serious health events reported.

Why is this trial important?

Nighttime hypoglycemia is a challenge for many people living with diabetes, especially those who use insulin. At night, while asleep, people are less likely to recognize symptoms of hypoglycemia. This can lead to longer exposure to low blood sugar levels, which can be harmful in both the short and long term.

Research suggests nighttime hypoglycemia is relatively common, with a global prevalence of 73%. People who skip meals (especially dinner), exercise before bedtime, have a lower A1C, and who experience daytime hypoglycemia are at a higher risk.

In a 2023 study of older adults with type 2 diabetes, about one-third of participants experienced nighttime hypoglycemia based on self-monitoring of blood glucose. Meanwhile, 65% of participants experienced nighttime hypoglycemia detected by CGM. This research suggests that many nighttime lows go undetected without CGM.

While CGM is an important tool to detect nighttime hypoglycemia, there are currently no treatments that directly address this diabetes complication. Current recommendations for nighttime lows are similar to those for daytime hypoglycemia: If you’re feeling low, you should check your blood sugar, and then consume carbohydrates or administer ready-to-use glucagon if needed. There’s a need for treatments that prevent and directly address nighttime hypoglycemia.

Are you interested?

You may be eligible to participate if you:

  • Are 18 to 75 years old and have had type 1 diabetes for at least five years

  • Have a history of recent nocturnal hypoglycemia

  • Have an A1C ≤10%

  • Have a BMI ≥18.5 and <33 kg/m2

People who use automated insulin delivery (AID) systems are not eligible. While this trial is not open to people with type 2 diabetes, Zucara is developing ZT-01 for both people with type 1 and with insulin-dependent type 2 diabetes, so future studies may be open to all people with diabetes.

The trial is currently recruiting in several locations throughout the US and Canada. See a full list of inclusion/exclusion criteria here.

Learn more about managing hypoglycemia:

Photo credit: iStock

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About the authors

April Hopcroft joined diaTribe in 2023 as a Staff Writer after co-leading the Diabetes Therapy team at Close Concerns. She graduated from Smith College in 2021, where she majored in... Read the full bio »