CompletedPhase 2Results posted

Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects

A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes

Lead sponsor

OPKO Health, Inc.

Asset

OPK88003

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Actual enrollment

113

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 27-45•HbA1c 7-10.5%

Primary endpoint

•HbA1c

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03406377

Org study IDDPO-203

Timeline

Milestones

Study first posted2018-01-23actual

Study start2018-04-02actual

Primary completion2019-03-08actual

Study completion2019-06-27actual

Last update posted2021-06-15actual

Results first posted2021-06-15actual

Assets

Investigational agents

OPK88003

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),

•BMI ≥27 and ≤45 kg/m2

•HbA1c ≥7.0% and ≤10.5% at screening

Exclusion criteria

•Type 1 diabetes mellitus

•Previous treatment with incretin mimetic drugs

•Have used insulin for diabetic control for more than 6 consecutive days within the prior year

•Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months

•Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (>2 x ULN).

Endpoints (4)

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

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Mean Percent (%) Body Weight Change

Time frame:From baseline to 30 weeks

descriptive

Secondary/protocol endpoint

Percent (%) of Subjects With 5% or Greater Body Weight Loss.

Time frame:30 weeks.

descriptive

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in HbA1c in Subjects With Type 2 DM

Time frame:From baseline to 30 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of Fasting Plasma Glucose (FPG).

Time frame:30 weeks.

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.