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CompletedPhase 2

A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Multi-Center Study to Evaluate the Efficacy and Safety of TTP273 Following 12 Weeks Administration in Subjects With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

Lead sponsor

vTv Therapeutics

Asset

TTP273

Oral · GLP-1 agonist

Listed sites

30

Recruiting sites

Enrollment

174

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

HbA1c, change

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 IDNCT02653599
Org study IDTTP273-201

Timeline

Milestones

Study first posted2016-01-12estimated
Last update posted2017-02-10actual
Study start2015-12 (month precision)
Primary completion2016-11actual (month precision)
Study completion2017-01actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

The subject has a 6 month diagnosis of Type 2 diabetes mellitus prior to screening and meets the American Diabetes Association (ADA) guidelines for Type 2 diabetes mellitus.
On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months prior to screening.
Males. Females of non-childbearing potential.
Generally stable health without a history of major surgery or significant injuries within the last year and without an active infection.

Exclusion criteria

Diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring Type 2 Diabetes, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis.
Participation in a clinical trial and receipt of an investigational product within 30 days.
Participation in any formal weight loss program, or fluctuation of > 5% in body weight, or having received medications approved for weight loss within 3 months prior to screening or contemplating such therapy during the trial.
Previous surgical treatment of obesity.
Have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice administered by someone other than the patient within 6 months prior to screening.
Use of other diabetic agents except metformin within 3 months prior to Screening.
History of pancreatitis.
Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to screening.
History of hemolytic anemia, chronic transfusion requirement or other condition rendering HbA1c results unreliable.
History of MEN-2 or family history of medullary thyroid cancer.
History or presence of clinically significant disease (other than Type 2 diabetes mellitus).

Endpoints (16)

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

Glycemic / diabetes
5
Safety / tolerability / PK
5
Cardiometabolic biomarkers
3
Other (unclassified)
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from baseline at 12 weeks

Time frame:Day 1 to Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Change in HbA1c from baseline at 12 weeks

Time frame:Day 1 to Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of subjects who achieve HbA1c <7% at 12 weeks

Time frame:Day 1 to Week 12

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in plasma glucose levels from baseline at 12 weeks

Time frame:Day 1 to Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in insulin levels from baseline at 12 weeks

Time frame:Day 1 to Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in C-peptide levels from baseline at 12 weeks

Time frame:Day 1 to Week 12

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint/low confidence

Change in lipid Levels from baseline at 12 weeks

Time frame:Day 1 to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Blood Pressure

Time frame:Day 1 to Week 14

change from baseline, improvement

Secondary/protocol endpoint

Pulse

Time frame:Day 1 to Week 14

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Adverse Events

Time frame:Day 1 to Week 14

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Electrocardiogram Parameters

Time frame:Day 1 to Week 14

descriptive

Secondary/protocol endpoint

Hematology

Time frame:Day 1 to Week 14

descriptive

Secondary/protocol endpoint

Blood Chemistry

Time frame:Day 1 to Week 14

descriptive

Secondary/protocol endpoint

Urinalysis

Time frame:Day 1 to Week 14

descriptive

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Change in glucagon levels from baseline at 12 weeks

Time frame:Day 1 to Week 12

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in glucagon-like peptide-1 levels from baseline at 12 weeks

Time frame:Day 1 to Week 12

change from baseline, descriptive

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.