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New daily pill aims to tame type 2 diabetes safely over the long haul

NCT ID NCT06010004

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests the long-term safety of an experimental oral drug called orforglipron in adults with type 2 diabetes whose blood sugar is not well controlled by diet, exercise, or other diabetes pills. Participants take the drug once daily for about a year, and researchers monitor for side effects and changes in blood sugar levels. The goal is to see if orforglipron can be a safe, long-term treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
orforglipron (LY3502970)
What this could lead to
If successful, this could provide a new, convenient once-daily oral option for managing type 2 diabetes long-term.
What could go wrong
This is a safety-focused study, so effectiveness is not the primary goal. Side effects may emerge, and results may not apply to all diabetes patients.

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

401 people

The number who actually took part.

Started

Sep 2023

Finished

Jun 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) as determined by the central laboratory at screening. * Are of stable weight (±5%) for at least 90 days prior to screening 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening. Exclusion Criteria: * Have Type 1 Diabetes (T1D). * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization. * Have New York Heart Association functional classification IV congestive heart failure. * Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization. * acute myocardial infarction * cerebrovascular accident (stroke), or * hospitalization for congestive heart failure * Have acute or chronic hepatitis and pancreatitis

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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

  • Fujii Clinic

    Ube, Yamaguchi, 755-0049, Japan

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031, Japan

  • Gibo Hepatology Clinic

    Matsumoto, Nagano, 399-0036, Japan

  • Hachioji Diabetes Clinic

    Hachioji-shi, Tokyo, 192-0083, Japan

  • Hasegawa Medical Clinic

    Chitose, Hokkaido, 066-0032, Japan

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008, Japan

  • Heiwadai Hospital

    Miyazaki, 880-0034, Japan

  • Jinnouchi Hospital

    Kumamoto, 862-0976, Japan

  • Kanno Naika

    Mitaka, Tokyo, 181-0013, Japan

  • Kansai Electric Power Hospital

    Osaka, 553-0003, Japan

  • Kashiwa City Hospital

    Kashiwa, Chiba, 277-0825, Japan

  • Kitada Clinic

    Osaka, Osaka, 538-0044, Japan

  • Matsuda Clinic

    Kobe, Hyōgo, 651-2135, Japan

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853, Japan

  • Medical Corporation Tao Internal Medicine Clinic

    Ube, Yamaguchi, 755-0047, Japan

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004, Japan

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime, 790-0034, Japan

  • MinamiAkatsukaClinic

    Mito, Ibaraki, 311-4153, Japan

  • Morinaga Ueno Clinic

    Kumamoto, 860-0863, Japan

  • Nakakinen clinic

    Naka, Ibaraki, 311-0113, Japan

  • Nakamoto Internal Medicine Clinic

    Mito, Ibaraki, 310-0826, Japan

  • Nakayama Clinic

    Nagoya, Aichi-ken, 456-0058, Japan

  • Nishiyamadou Keiwa Hospital

    Naka, Ibaraki, 311-0133, Japan

  • OHAMA Diabetes Clinic

    Kawaguchi, Saitama, 332-0015, Japan

  • Odori Diabetes

    Sapporo, Hokkaido, 060-0001, Japan

  • Seiwa Clinic

    Adachi-ku, Tokyo, 120-0011, Japan

  • Shinkashiwa Clinic

    Kashiwa, Chiba, 277-0084, Japan

  • Shiraiwa Medical Clinic

    Kashihara, Osaka, 582-0005, Japan

  • Shonan Takai Clinic

    Kamakura, Kanagawa, 247-0055, Japan

  • Steel Memorial Yawata Hospital

    Kitakyushu, Fukuoka, 805-8508, Japan

  • Sugiura Internal Medicine Clinic

    Sōka, Saitama, 340-0015, Japan

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056, Japan

  • Tashiro Endocrinology Clinic

    Fukuoka, 814-0153, Japan

  • Taya Clinic Koueikai Medical Corporation

    Tsuchiura, Ibaraki, 300-0047, Japan

  • The Institute for Adult Disease, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002, Japan

  • Tokuyama Clinic

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

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027, Japan

  • Yokkaichi Diabetes Clinic

    Yokkaichi, Mie-ken, 510-0829, Japan

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa, 232-0064, Japan

More trials for these conditions

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