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COMPLETED Phase 3

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

NCT03353350 · View on ClinicalTrials.gov ↗

Study Summary

Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. Secondary Objectives: * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight * To evaluate the safety of once-weekly injection of efpeglenatide

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG efpeglenatide (SAR439977)

Study Locations (20)

California

  • Investigational Site Number 8400003 — Canoga Park
  • Investigational Site Number 8400007 — Chula Vista
  • Investigational Site Number 8400011 — La Mesa
  • Investigational Site Number 8400009 — Los Angeles
  • Investigational Site Number 8400029 — Pomona
  • Investigational Site Number 8400024 — Tarzana
  • Investigational Site Number 8400026 — Van Nuys

Florida

  • Investigational Site Number 8400010 — DeLand
  • Investigational Site Number 8400006 — Hialeah
  • Investigational Site Number 8400032 — West Palm Beach

Nevada

  • Investigational Site Number 8400062 — Las Vegas
  • Investigational Site Number 8400021 — Las Vegas

Alabama

  • Investigational Site Number 8400004 — Birmingham

Arizona

  • Investigational Site Number 8400005 — Glendale

Georgia

  • Investigational Site Number 8400025 — Lawrenceville

Illinois

  • Investigational Site Number 8400034 — Chicago

Missouri

  • Investigational Site Number 8400033 — Kansas City

Trial Details

FieldValue
Enrollment Target 406 participants
Start Date 2017-12-05
Est. Completion 2020-09-07
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03353350

The ClinicalTrials.gov registry entry for NCT03353350 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 98 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03353350 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03353350 about?

NCT03353350 is a clinical study titled "Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise". Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. Secondary Objectives: * To demonstrate th...

What is the current status of trial NCT03353350?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2017-12-05. Estimated completion is 2020-09-07.

What conditions does trial NCT03353350 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03353350?

The interventions under investigation include: placebo (DRUG), efpeglenatide (SAR439977) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03353350?

This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 98 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03353350 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial