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

Type 2 Diabetes Clinical Trial

— ACHIEVE-5  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109311
• Other study ID #: 18567
• Secondary ID: J2A-MC-GZGWU1111
• Status: Recruiting
• Phase: Phase 3
• Start date: November 10, 2023
• Est. completion date: June 25, 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: June 25, 2025
• Est. primary completion date: June 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Orforglipron
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Brazil	L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192	Brasília	Distrito Federal
Brazil	Pesquisa Clínica em Diabetes - Dra Rosângela Réa	Curitiba	Paraná
Brazil	Insight Centro de Pesquisas	Porto Alegre	Rio Grande Do Sul
Brazil	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro
Brazil	Centro Multidisciplinar de Estudos Clinicos	Sao Bernardo do Campo	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
China	Beijing Hospital	Beijing	Beijing
China	Chongqing General Hospital	Chongqing	Chongqing
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Japan	Hasegawa Medical Clinic	Chitose	Hokkaido
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	The Institute for Adult Disease, Asahi Life Foundation	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Matoba Internal Medicine Clinic	Ebina	Kanagawa
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Shiraiwa Medical Clinic	Kashiwara	Osaka
Japan	Jinnouchi Hospital	Kumamoto
Japan	Tokuyama Clinic	Mihama-ku,Chiba City	Chiba
Japan	MinamiAkatsukaClinic	Mito	Ibaraki
Japan	Abe Clinic	Oita
Japan	Medical Corporation Sato Medical clinic	Ootaku	Tokyo
Japan	Kansai Electric Power Hospital	Osaka
Japan	Tama Center Clinic Mirai	Tama	Tokyo
Puerto Rico	Centro de Endocrinologia y Nutricion	Caguas
Puerto Rico	FDI Clinical Research	San Juan
Romania	CMI DNBM Dr. Pop Lavinia	Baia Mare	Maramure?
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Centrul Medical Endocrinologie si Diabet Dr. Paveliu	Bucharest	Bucure?ti
Romania	Centrul Medical NutriLife	Bucharest	Bucuresti
Romania	Geea Medical Easy Diet	Bucharest	Bucure?ti
Romania	Diamed Obesity	Gala?i
Romania	Milena Sante	Gala?i
Romania	Diabdana	Oradea	Bihor
Romania	Clinica Korall	Satu Mare
Romania	SC Dentosim Queen SRL - Centrul Medical Diamed	Târgu Mure?	Mure?
United States	Bingham Memorial Hospital	Blackfoot	Idaho
United States	Humphreys Diabetes Center	Boise	Idaho
United States	SanRo Clinical Research Group	Bryant	Arkansas
United States	MD First Research - Chandler	Chandler	Arizona
United States	Velocity Clinical Research, Mt. Auburn	Cincinnati	Ohio
United States	Orita Clinical Research	Decatur	Georgia
United States	CMR of Greater New Haven	Hamden	Connecticut
United States	Encore Medical Research	Hollywood	Florida
United States	The Research Group of Lexington	Lexington	Kentucky
United States	Loma Linda University Health System	Loma Linda	California
United States	Lifedoc Research - Lenox Park Drive	Memphis	Tennessee
United States	Tristar Clinical Investigations	Philadelphia	Pennsylvania
United States	Phoenix Clinical LLC	Phoenix	Arizona
United States	Western University of Health Sciences	Pomona	California
United States	Frontier Clinical Research, LLC	Scottdale	Pennsylvania
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Clinvest Research LLC	Springfield	Missouri
United States	Richmond University Medical Center	Staten Island	New York
United States	Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.	Toluca Lake	California
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Encore Medical Research - Weston	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Brazil,  China,  Japan,  Puerto Rico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 40
Secondary	Orforglipron Dose 3: Change from Baseline in HbA1c		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))		Baseline to Week 40
Secondary	Percentage of Participants Who Achieved HbA1c =6.5% (48 mmol/mol)		Baseline to Week 40
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 40
Secondary	Percentage Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol		Baseline, Week 40
Secondary	Percentage Change from Baseline in Triglycerides		Baseline, Week 40
Secondary	Change from Baseline in Systolic Blood Pressure		Baseline, Week 40
Secondary	Change from Baseline in Daily Insulin Glargine Dose		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =5%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =10%		Baseline to Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =15% from Baseline		Baseline to Week 40
Secondary	Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores		Baseline, Week 40

External Links

•   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 (ACHIEVE-5)