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New daily pill aims to improve blood sugar in type 2 diabetes

NCT ID NCT06109311

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a once-daily pill called orforglipron in 546 adults with type 2 diabetes whose blood sugar was not well controlled despite using insulin (with or without other diabetes medications). The goal was to see if adding orforglipron could safely lower blood sugar levels better than a placebo. The study lasted about 46 weeks and measured changes in HbA1c, a key marker of long-term blood sugar control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

546 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • Abe Clinic

    Ōita, 870-0039, Japan

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100051, China

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221, United States

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283, Romania

  • CEDOES

    Vitória, Espírito Santo, 29055450, Brazil

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureş, 430222, Romania

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517, United States

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000, Brazil

  • Care Access - Brandon

    Brandon, Florida, 33510, United States

  • Centro Multidisciplinar de Estudos Clinicos

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • Centro de Endocrinologia y Nutricion

    Caguas, 00725, Puerto Rico

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13060-803, Brazil

  • Centrul Medical Endocrinologie si Diabet Dr. Paveliu

    Bucharest, Bucharest, 50538, Romania

  • Centrul Medical NutriLife

    Bucharest, Bucharest, 013764, Romania

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 401147, China

  • Clinica Korall

    Satu Mare, 440055, Romania

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807, United States

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606, United States

  • Diabdana

    Oradea, Bihor County, 410147, Romania

  • Diamed Obesity

    Galați, 800291, Romania

  • Encore Medical Research

    Hollywood, Florida, 33024, United States

  • Encore Medical Research - Weston

    Weston, Florida, 33331, United States

  • FDI Clinical Research

    San Juan, 00927, Puerto Rico

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683, United States

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031, Japan

  • Geea Medical Easy Diet

    Bucharest, Bucharest, 010627, Romania

  • Hasegawa Medical Clinic

    Chitose, Hokkaido, 066-0032, Japan

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180, Brazil

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo, 12243-280, Brazil

  • Insight Centro de Pesquisas

    Porto Alegre, Rio Grande do Sul, 90560-003, Brazil

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Jinnouchi Hospital

    Kumamoto, 862-0976, Japan

  • Kansai Electric Power Hospital

    Osaka, 553-0003, Japan

  • L2IP - Instituto de Pesquisas Clínicas

    Brasília, Federal District, 70200730, Brazil

  • Lifedoc Research - Lenox Park Drive

    Memphis, Tennessee, 38115, United States

  • Loma Linda University Health System

    Loma Linda, California, 92350, United States

  • MD First Research - Chandler

    Chandler, Arizona, 85286, United States

  • Matoba Internal Medicine Clinic

    Ebina, Kanagawa, 243-0432, Japan

  • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

    Toluca Lake, California, 91602, United States

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo, 143-0015, Japan

  • Milena Sante

    Galați, 800001, Romania

  • MinamiAkatsukaClinic

    Mito, Ibaraki, 311-4153, Japan

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210012, China

  • Orita Clinical Research

    Decatur, Georgia, 30034, United States

  • Phoenix Clinical LLC

    Phoenix, Arizona, 85014, United States

  • Quanta Diagnóstico e Terapia

    Curitiba, Paraná, 80040-110, Brazil

  • Richmond University Medical Center

    Staten Island, New York, 10310, United States

  • SC Dentosim Queen SRL - Centrul Medical Diamed

    Târgu Mureş, Mureș County, 540098, Romania

  • SanRo Clinical Research Group

    Bryant, Arkansas, 72022, United States

  • Shiraiwa Medical Clinic

    Kashihara, Osaka, 582-0005, Japan

  • St. Luke's Humphreys Diabetes Center: Boise

    Boise, Idaho, 83702, United States

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056, Japan

  • Tama Center Clinic Mirai

    Tama, Tokyo, 206-0633, Japan

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596, United States

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan, 471003, China

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002, Japan

  • The Research Group of Lexington

    Lexington, Kentucky, 40503, United States

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011, China

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014, China

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230011, China

  • Tokuyama Clinic

    Mihama-ku,Chiba City, Chiba, 261-0004, Japan

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027, Japan

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania, 19114, United States

  • Velocity Clinical Research, Gardena

    Gardena, California, 90247, United States

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio, 45219, United States

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001, China

  • Western University of Health Sciences

    Pomona, California, 91766, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.