--- title: Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise nct_id: NCT03353350 overall_status: COMPLETED phase: PHASE3 sponsor: Hanmi Pharmaceutical Company Limited study_type: INTERVENTIONAL primary_condition: Type 2 Diabetes Mellitus countries: United States, Germany, Poland, Ukraine, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03353350.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03353350" ct_last_update_post_date: 2022-01-18 last_seen_at: "2026-05-12T06:51:54.130Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise **Official Title:** A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise **NCT ID:** [NCT03353350](https://clinicaltrials.gov/study/NCT03353350) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 406 - **Lead Sponsor:** Hanmi Pharmaceutical Company Limited - **Collaborators:** Sanofi - **Conditions:** Type 2 Diabetes Mellitus - **Start Date:** 2017-12-05 - **Completion Date:** 2020-09-07 - **CT.gov Last Update:** 2022-01-18 ## Brief 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 ## Detailed Description Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion criteria: * Participants must be at least 18 years of age at the time of signing the informed consent. * Participants with T2DM, and treated with diet and exercise. * Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening. Exclusion criteria: * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying. * History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy. * Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes). * Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery. * Body weight change of ≥5 kg within the last 3 months prior to Screening. * Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg at Randomization. * End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease \[MDRD\]) of \<15 mL/min/1.73 m2. * Laboratory findings at the Screening Visit: * Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) \>3 times the upper limit of the normal (ULN ) or total bilirubin \>1.5 times the ULN (except in case of documented Gilbert's syndrome). * Amylase and/or lipase: \>3 times the ULN laboratory range. * Calcitonin ≥5.9 pmol/L (20 pg/mL). * Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period. * History of drug or alcohol abuse within 6 months prior to the time of Screening. * Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women. * Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ``` ## Arms - **Efpeglenatide 2mg** (EXPERIMENTAL) — Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks - **Efpeglenatide 4 mg** (EXPERIMENTAL) — Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) - **Efpeglenatide 6 mg** (EXPERIMENTAL) — Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) - **Placebo** (PLACEBO_COMPARATOR) — Matching placebo (Prefilled syringe) administered once weekly for 56 weeks ## Interventions - **efpeglenatide (SAR439977)** (DRUG) — Pharmaceutical form: solution for injection Route of administration: subcutaneous - **placebo** (DRUG) — Pharmaceutical form: solution for injection Route of administration: subcutaneous ## Primary Outcomes - **Change in Glycated Hemoglobin (HbA1c) (%)** _(time frame: Baseline to Week 30)_ — Change from Baseline to Week 30 in HbA1c ## Secondary Outcomes - **Change in HbA1c (%)** _(time frame: Baseline to Week 56)_ - **Change in Fasting Plasma Glucose (FPG)** _(time frame: Baseline to Week 30)_ - **HbA1c <7%** _(time frame: Week 30)_ - **Change in Body Weight at Week 30** _(time frame: Baseline to Week 30)_ - **Change in Body Weight at Week 56** _(time frame: Baseline to Week 56)_ - **Hypoglycemic Participants** _(time frame: Baseline to Week 56)_ - **Hypoglycemic Events** _(time frame: Baseline to Week 56)_ - **Treatment Emergent Adverse Events (TEAEs)** _(time frame: Baseline to Week 56)_ ## Locations (54) - Investigational Site Number 8400004, Birmingham, Alabama, United States - Investigational Site Number 8400005, Glendale, Arizona, United States - Investigational Site Number 8400003, Canoga Park, California, United States - Investigational Site Number 8400007, Chula Vista, California, United States - Investigational Site Number 8400011, La Mesa, California, United States - Investigational Site Number 8400009, Los Angeles, California, United States - Investigational Site Number 8400029, Pomona, California, United States - Investigational Site Number 8400024, Tarzana, California, United States - Investigational Site Number 8400026, Van Nuys, California, United States - Investigational Site Number 8400010, DeLand, Florida, United States - Investigational Site Number 8400006, Hialeah, Florida, United States - Investigational Site Number 8400032, West Palm Beach, Florida, United States - Investigational Site Number 8400025, Lawrenceville, Georgia, United States - Investigational Site Number 8400034, Chicago, Illinois, United States - Investigational Site Number 8400033, Kansas City, Missouri, United States - Investigational Site Number 8400018, Lincoln, Nebraska, United States - Investigational Site Number 8400062, Las Vegas, Nevada, United States - Investigational Site Number 8400021, Las Vegas, Nevada, United States - Investigational Site Number 8400001, Bridgeton, New Jersey, United States - Investigational Site Number 8400028, Burlington, North Carolina, United States - Investigational Site Number 8400031, Wilmington, North Carolina, United States - Investigational Site Number 8400013, Maumee, Ohio, United States - Investigational Site Number 8400008, Hatboro, Pennsylvania, United States - Investigational Site Number 8400017, Carrollton, Texas, United States - Investigational Site Number 8400030, Dallas, Texas, United States - Investigational Site Number 8400015, Houston, Texas, United States - Investigational Site Number 8400019, Plano, Texas, United States - Investigational Site Number 8400020, San Antonio, Texas, United States - Investigational Site Number 8400016, San Antonio, Texas, United States - Investigational Site Number 8400027, San Antonio, Texas, United States - Investigational Site Number 8400023, Schertz, Texas, United States - Investigational Site Number 8400002, Holladay, Utah, United States - Investigational Site Number 2760005, Berlin, Germany - Investigational Site Number 2760003, Frankfurt am Main, Germany - Investigational Site Number 2760001, Leipzig, Germany - Investigational Site Number 6160005, Gdansk, Poland - Investigational Site Number 6160004, Gdynia, Poland - Investigational Site Number 6160007, Katowice, Poland - Investigational Site Number 6160002, Krakow, Poland - Investigational Site Number 6160006, Poznan, Poland - Investigational Site Number 6160003, Warsaw, Poland - Investigational Site Number 6160001, Wroclaw, Poland - Investigational Site Number 8040003, Kyiv, Ukraine - Investigational Site Number 8040001, Kyiv, Ukraine - Investigational Site Number 8040002, Kyiv, Ukraine - Investigational Site Number 8040004, Vinnitsa, Ukraine - Investigational Site Number 8260005, Birmingham, United Kingdom - Investigational Site Number 8260004, Cardiff, United Kingdom - Investigational Site Number 8260007, Chorley, United Kingdom - Investigational Site Number 8260008, Glasgow, United Kingdom - Investigational Site Number 8260001, Hexham, United Kingdom - Investigational Site Number 8260003, Liverpool, United Kingdom - Investigational Site Number 8260006, Manchester, United Kingdom - Investigational Site Number 8260002, Reading, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `locations.investigational site number 8400024|tarzana|california|united states` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.investigational site number 8400004|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400005|glendale|arizona|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400003|canoga park|california|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400007|chula vista|california|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400011|la mesa|california|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400009|los angeles|california|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400029|pomona|california|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400026|van nuys|california|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400010|deland|florida|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400006|hialeah|florida|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400032|west palm beach|florida|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400025|lawrenceville|georgia|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400034|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400033|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400018|lincoln|nebraska|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400062|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400021|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400001|bridgeton|new jersey|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400028|burlington|north carolina|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400031|wilmington|north carolina|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400013|maumee|ohio|united states` — added _(2026-05-12)_ - `locations.investigational site number 6160007|katowice||poland` — added _(2026-05-12)_ - `locations.investigational site number 8400008|hatboro|pennsylvania|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400017|carrollton|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400030|dallas|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400015|houston|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400019|plano|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400020|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400016|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400027|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400023|schertz|texas|united states` — added _(2026-05-12)_ - `locations.investigational site number 8400002|holladay|utah|united states` — added _(2026-05-12)_ - `locations.investigational site number 2760005|berlin||germany` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03353350.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03353350* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*