Zucara’s New Drug Aims to Prevent Overnight Lows in Type 1 Diabetes

But what if there were a medication designed specifically to prevent hypoglycemia (low blood sugar) episodes? 

That’s exactly what Zucara Therapeutics, a small biotech company based in Canada, is working on. Their investigational therapy, called ZT-01, is currently in Phase 2 clinical trials in both the United States and Canada. (Learn more about other T1D clinical trials here.)

Right now, they’re recruiting participants with type 1 diabetes.

Why doesn’t your body already prevent lows?

If you live with type 1 diabetes (T1D), you know that your pancreas no longer produces insulin because your immune system destroyed your beta cells. But here’s what many people don’t realize: beta cells do much more than just make insulin.

They also communicate with other pancreatic cells, such as alpha cells and delta cells, which manage the hormones glucagon and somatostatin.

• Alpha cells normally release glucagon, which tells your liver to release its backup fuel: stored glucose (called glycogen).
• Delta cells release somatostatin, which helps regulate how much insulin and glucagon your beta and alpha cells make.

When your blood sugar drops, your beta cells are supposed to tell the alpha cells to release glucagon and tell the delta cells to back off. That way, your liver knows to release glucose and bring your blood sugar back up.

But in type 1 diabetes, your beta cells are toast. That entire communication system is broken. Which means your body doesn’t protect you from hypoglycemia the way it should.

How Zucara’s ZT-01 Works

Zucara’s therapy, ZT-01, is designed to fix that broken system.

ZT-01 targets somatostatin — the hormone that essentially blocks your liver from releasing glucose during a low. By calming down the production of somatostatin, ZT-01 allows your liver to release stored glucose when your blood sugar drops.

Think of it like restoring the body’s natural safety net against hypoglycemia.

And here’s an important detail: once your blood sugar reaches about 90 mg/dL, ZT-01’s effect turns off. That means your glucose rises back to a safe range without spiking.

What the clinical trials have shown so far

• Phase 1 trial: ZT-01 was found to be safe and well-tolerated in people with type 1 diabetes.
• Phase 1b (proof-of-concept): The drug successfully restored glucagon production and helped participants prevent low blood sugars.
• Phase 2 trial (now recruiting): Researchers are studying how well ZT-01 prevents overnight lows — some of the most dangerous and disruptive hypoglycemia events people with type 1 face.

Why overnight? Because middle-of-the-night lows often go unnoticed, they can lead to seizures or unconsciousness, and they obviously wreck sleep quality, too. Since ZT-01 lasts long enough to cover nighttime hours with a single injection, this phase of the study focuses specifically on nocturnal hypoglycemia.

Most importantly, Zucara is also working on developing longer-lasting versions of the drug — including daily and even once-weekly injections, similar to how other modern diabetes and weight management medications have evolved.

Who can participate in the study?

You may qualify if:

• You’ve lived with type 1 diabetes for at least 5 years
• You’re between 18 and 75 years old
• You experience frequent overnight lows
• Your A1c is under 10%
• Your BMI is between 18.5 and 33
• You live near one of the clinical trial sites in the U.S. or Canada

If you don’t already use a CGM, one will be provided for the study. Pump users — including those on hybrid closed-loop systems — can also participate.

Where are the study sites?

In the United States:

• Los Angeles, CA
• Jacksonville, FL
• West Palm Beach, FL
• Las Vegas, NV
• Macon, GA
• Morehead City, NC
• Austin, TX
• San Antonio, TX

In Canada:

• Alberta
• Vancouver
• Calgary
• Toronto
• Concord
• And more!

Why this matters

Low blood sugars are more than just frustrating. They can be frightening, dangerous, and life-changing.

• For kids and their parents, they’re a constant fear.
• For teens and young adults, they disrupt school, independence, and safety.
• For adults and parents, they interfere with work, caregiving, and peace of mind.
• For older adults, they can cause devastating falls, confusion, or hospitalizations.
• For people with hypoglycemia unawareness.

If successful, ZT-01 could be the first medication of its kind to prevent hypoglycemia in people taking insulin.

Want to learn more or see if you qualify?

Visit T1Dexchange.org/Zucara to check eligibility and find the nearest study site.