Type 1 Diabetes Mellitus With Hypoglycemia study: ZT-01
Official title A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05762107
What this study is testing
What is ZT-01?
an investigational daily injectable medicine being studied for preventing nighttime low blood sugar in adults with type 1 diabetes. is designed to increase the amount of glucagon during low blood sugar episodes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ZT-01 lowers the number of night‑time low blood sugar episodes in adults with type 1 diabetes and how safe it is.
- Who it's for
- You may be able to join if you are an adult with type 1 diabetes who experiences low blood sugar at night.
- What's involved
- You will inject the study drug or a pretend treatment before bed for two 4‑week periods while wearing a study‑provided continuous glucose monitor. You will keep a short nightly diary, upload glucose data each day, and attend study visits for blood, urine, blood pressure, temperature and heart checks.
- Time commitment
- The study lasts about 16 weeks and includes six clinic visits, two phone calls, and overnight stays for four measurement sessions.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Has type 1 diabetes for at least 5 years
- is at risk of nocturnal hypoglycemia (if using personal CGM, time below 54 mg/dL at least 1% over previous 4 weeks at screening
- HbA1c at screening \</= 10.0%
- Body mass index (BMI) at screening \>/=18.5 to \<33 kg/m2
You likely can't join if
- Has been hospitalized for diabetic ketoacidosis (DKA) more than once within previous 6 months
- Has experienced \>/= 1 severe hypoglycemia (requiring assistance) during previous 4 weeks or \>2 in previous 3 months
- Diagnosis of type 2 diabetes, pheochromocytoma, insulinoma, glucagonoma, acromegaly, Cushing's disease, glycogen storage disease, adrenal...
- Clinically significant kidney disease
- Abnormal liver function
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Escondido, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- New Port Richey, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Lawrenceville, Georgia, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Flint, Michigan, United States
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Escondido, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 35 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.