Clinical trial NCT05048719: A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Official title: A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
* Have a stable body weight for the 3 months prior to randomization
* Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
* Males must agree to use highly effective methods of contraception
* Women not of childbearing potential (WNOCBP) may participate in this trial
* Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

Exclusion Criteria:

* Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
* Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
* Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
* Have acute or chronic pancreatitis
* Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
* Have gastric emptying abnormality or chronically take medications impacting GI motility
* Have poorly controlled hypertension
* Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
* Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
* Have HIV, or Hepatitis B or Hepatitis C

Primary outcomes:
measure: Change From Baseline in HbA1c in LY3502970 as Compared to Placebo
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide
timeFrame: Baseline, Week 26
measure: Percentage of Participants With HbA1c ≤ 6.5%
timeFrame: Week 26
measure: Percentage of Participants With HbA1c <7.0%
timeFrame: Week 26
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 26
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 26
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970
timeFrame: Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Vallejo
country: United States
facility: Touro University California
state: California
city: Golden
country: United States
facility: New West Physicians Clinical Research
state: Colorado
city: Monument
country: United States
facility: Optumcare Colorado Springs - Monument
state: Colorado
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Care
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Gyongyos
country: Hungary
facility: Bugát Pál Kórház
state: Heves
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Korhaz
state: Zala
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház
state: Zala
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: ClinDiab Kft.
city: Budapest
country: Hungary
facility: TRANTOR'99 Bt. Anyagcsere Centrum
city: Budapest
country: Hungary
facility: Strazsahegy Medicina Bt.
city: Wrocław
country: Poland
facility: Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej
state: Dolnośląskie
city: Lublin
country: Poland
facility: Gabinety TERPA
state: Lubelskie
city: Lublin
country: Poland
facility: NZOZ Medica
state: Lubelskie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
state: Mazowieckie
city: Wierzchosławice
country: Poland
facility: Centrum Zdrowia Tuchów
state: Małopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Ruda Slaska
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
state: Śląskie
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex
city: Ponce
country: Puerto Rico
facility: Clinical Research Management Group Inc. - Hospital San Cristobal
city: San Juan
country: Puerto Rico
facility: BRCR Global Puerto Rico-Unda
city: Bratislava
country: Slovakia
facility: Ambulancia diabetológie a porúch látkovej premeny a výživy - DIABEDA
state: Bratislavský Kraj
city: Prešov
country: Slovakia
facility: Diabetol
state: Prešovský Kraj
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
state: Prešovský Kraj
city: Puchov
country: Slovakia
facility: DIA-MED CENTRUM s.r.o.
state: Trenčiansky Kraj
city: Nove Zamky
country: Slovakia
facility: Funkystuff
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: