Clinical trial NCT06109311: A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
Official title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 520
Sex: ALL
Minimum age (years): 18
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 determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.


Eligibility criteria: Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% \[53 mmol/mol\] to ≤10.5% \[91 mmol/mol\]
* Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:

  * insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
  * insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
  * metformin, or
  * SGLT-2 inhibitor, or
  * both metformin and SGLT-2 inhibitor.
* Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a Body Mass Index (BMI) ≥23.0 kg/m\^2 at baseline.

Exclusion Criteria:

* Have New York Heart Association functional classification III-IV congestive heart failure.
* Have had any of the following cardiovascular conditions within 60 days prior to baseline.

  * acute myocardial infarction
  * cerebrovascular accident (stroke), or
  * hospitalization for congestive heart failure.
* Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
* Have had chronic or acute pancreatitis any time.

Primary outcomes:
measure: Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Orforglipron Dose 3: Change from Baseline in HbA1c
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
timeFrame: Baseline to Week 40
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Triglycerides
timeFrame: Baseline, Week 40
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: Baseline, Week 40
measure: Change from Baseline in Daily Insulin Glargine Dose
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥5%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥10%
timeFrame: Baseline to Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline
timeFrame: Baseline to Week 40
measure: Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores
timeFrame: Baseline, Week 40
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research - Chandler
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC
state: Arizona
city: Bryant
country: United States
facility: SanRo Clinical Research Group
state: Arkansas
city: Gardena
country: United States
facility: Velocity Clinical Research, Gardena
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health System
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: Toluca Lake
country: United States
facility: Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Brandon
country: United States
facility: Care Access - Brandon
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Decatur
country: United States
facility: Orita Clinical Research
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Boise
country: United States
facility: St. Luke's Humphreys Diabetes Center: Boise
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Lexington
country: United States
facility: The Research Group of Lexington
state: Kentucky
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Mt. Auburn
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Memphis
country: United States
facility: Lifedoc Research - Lenox Park Drive
state: Tennessee
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas
state: Distrito Federal
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Quanta Diagnóstico e Terapia
state: Paraná
city: Porto Alegre
country: Brazil
facility: Insight Centro de Pesquisas
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clinicos
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Mito
country: Japan
facility: MinamiAkatsukaClinic
state: Ibaraki
city: Ebina
country: Japan
facility: Matoba Internal Medicine Clinic
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Ootaku
country: Japan
facility: Medical Corporation Sato Medical clinic
state: Tokyo
city: Tama
country: Japan
facility: Tama Center Clinic Mirai
state: Tokyo
city: Kumamoto
country: Japan
facility: Jinnouchi Hospital
city: Oita
country: Japan
facility: Abe Clinic
city: Osaka
country: Japan
facility: Kansai Electric Power Hospital
city: Caguas
country: Puerto Rico
facility: Centro de Endocrinologia y Nutricion
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Oradea
country: Romania
facility: Diabdana
state: Bihor
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Bucharest
country: Romania
facility: Geea Medical Easy Diet
state: București
city: Bucharest
country: Romania
facility: Centrul Medical NutriLife
state: București
city: Bucharest
country: Romania
facility: Centrul Medical Endocrinologie si Diabet Dr. Paveliu
state: București
city: Baia Mare
country: Romania
facility: CMI DNBM Dr. Pop Lavinia
state: Maramureș
city: Târgu Mureș
country: Romania
facility: SC Dentosim Queen SRL - Centrul Medical Diamed
state: Mureș
city: Galați
country: Romania
facility: Milena Sante
city: Galați
country: Romania
facility: Diamed Obesity
city: Satu Mare
country: Romania
facility: Clinica Korall
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: