A Study With NLY01 in Subjects With Type 2 Diabetes

Neuraly

Status and phase: Completed; Phase 2

Conditions: Type2 Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: NLY01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04159766

NLY01-D1

Details and patient eligibility

About

This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subject with type 2 diabetes for at least one year
• Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic
• Body Mass Index (BMI) 22.0 to 35.0 kg/m^2,

Exclusion criteria

• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator
• Any prior exposure to an exenatide-based product (BYETTA and BYDUREON)
• History of gastroparesis
• History of severe hypoglycemia in the past 6 months
• If female, pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

NLY01 (2.5 mg)

Active Comparator group

Treatment:

Drug: NLY01

NLY01 (5.0 mg)

Active Comparator group

Treatment:

Drug: NLY01

NLY01 (10 mg)

Active Comparator group

Treatment:

Drug: NLY01

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo