GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide

Lead sponsor

Intarcia Therapeutics

Assets

Exenatide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

136

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c ≤9.5%

Primary endpoint

•Nausea (Nausea, Vomiting)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02638805

Org study IDITCA 650-CLP-201

Timeline

Milestones

Study first posted2015-12-23estimated

Last update posted2018-11-05actual

Study start2015-12 (month precision)

Primary completion2017-10actual (month precision)

Study completion2017-10actual (month precision)

Assets

Investigational agents

Exenatide Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of type 2 diabetes ≥ 3 months.

•Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.

•HbA1c ≤9.5%.

•Stable body weight ≥ 3 months.

•Body mass index (BMI) ≥25 to ≤45 kg per meter squared.

•Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit.

Exclusion criteria

•History of type 1 diabetes.

•Recent use or of anti-diabetic medications other than liraglutide or metformin.

•History of significant/severe nausea and/or vomiting due to liraglutide.

•Significant symptomatic hyperglycemia.

•History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.

•History or evidence of acute or chronic pancreatitis.

•History of liver disease.

•History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.

•Poor thyroid, liver, or renal function.

•Serum creatinine levels >1.5mg/dL (132 μmol/L) for male patients, or >1.4 mg/dL (123 μmol/L) for female patients.

•Weight loss surgery or requires weight loss medications.

•History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).

•History of active alcohol or substance abuse.

•Treatment with medications that affect GI motility.

•History of hypersensitivity to exenatide or liraglutide.

•Women that are pregnant, lactating, or planning to become pregnant.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:from baseline to Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in percentage of glycosylated hemoglobin (HbA1c) in the blood

Time frame:From baseline to Week 26

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Change from baseline in fasting plasma glucose

Time frame:from baseline to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

2 endpoints

Other/protocol endpoint

Change from baseline in blood pressure and heart rate

Time frame:from baseline to 34 weeks

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Other/protocol endpoint

Change from baseline in cholesterol

Time frame:from baseline to Week 26

change from baseline, improvement

componentsLDL-C, change, HDL-C, change

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting

Time frame:From Randomization to 34 weeks

Nausea

descriptive, event

componentsNausea, Vomiting

Secondary/protocol endpoint

Number (percentage) and severity of all treatment-emergent adverse events

Time frame:From Randomization to 34 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Incidence of hypoglycemia

Time frame:From Randomization to 34 weeks

Documented hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.