Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2019-10-16
2020-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NLY01 (2.5 mg)
NLY01
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
NLY01 (5.0 mg)
NLY01
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
NLY01 (10 mg)
NLY01
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Placebo
Placebo
normal saline
Interventions
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NLY01
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Placebo
normal saline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Neuraly, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Lee
Role: STUDY_DIRECTOR
Neuraly, Inc.
Locations
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Profil Institute fur Stoffwechselforschung GmbH
Neuss, , Germany
Profil Institute
Neuss, , Germany
Countries
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Other Identifiers
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NLY01-D1
Identifier Type: -
Identifier Source: org_study_id
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