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New pill aims to slash severe hypoglycemia in type 1 diabetes

NCT ID NCT06334133

Disease control Sponsor: vTv Therapeutics 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Updated 2 times

Summary

This study tests an experimental pill called cadisegliatin taken alongside insulin in adults with type 1 diabetes. The goal is to see if it can lower the number of dangerously low blood sugar events (hypoglycemia) without worsening overall blood sugar control. About 150 participants will receive either the pill or a placebo for 26 weeks.

Why investors are watching

vTv Therapeutics runs a Phase 3 trial of cadisegliatin as an add-on to insulin in 150 people with type 1 diabetes. For a micro-cap company, a late-stage result like this can decide whether the drug moves toward approval or the program stalls.

If it works: A positive result could support a regulatory filing and give the company a late-stage asset it can advance or partner. That may open new funding or partnership options.

If it fails: A failed or delayed result could end the program and leave the company without a late-stage candidate. Phase 3 trials often fail, and a small company has fewer resources to absorb that.

AI-written from the trial record. Speculative, and not investment advice.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

May 2027

An estimate. End dates often move.

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: * Individuals ≥18 years * Diagnosed T1DM with a minimum of 3 years since diagnosis * Has had at least 1 hypoglycemic event of Level 2 (glucose level \<54 mg/dL or \<3 mmol/L, \[CGM or SMBG confirmed\]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening * HbA1c value of \<9.5% at Screening * Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study * Must have been on a CGM device for at least 3 months prior to Screening Exclusion Criteria: * Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease * Has been hospitalized for DKA within 3 months prior to Screening * Has uncontrolled hypothyroidism or hyperthyroidism * History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight * Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ * Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) or weight loss medications within 30 days prior to the Screening * Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study. * Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening * Has uncontrolled hypertension prior to Screening

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Diabetes mellitus, type 1

Contacts and locations

Locations

  • 310 Clinical Research

    Inglewood, California, 90301, United States

  • AMC Community Endocrinology

    Albany, New York, 12203, United States

  • AME Clinical Research

    Huntington Beach, California, 92647, United States

  • Accellacare - McFarland

    Ames, Iowa, 50010, United States

  • Acclaim Clinical Research

    San Diego, California, 92120, United States

  • Amicis Research Center

    Granada Hills, California, 91344, United States

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205, United States

  • BayCare Health Systems

    Clearwater, Florida, 33756, United States

  • Centricity Research - Columbus

    Columbus, Georgia, 31904, United States

  • Centricity Research Morehead City Multispecialty

    Morehead City, North Carolina, 28557, United States

  • Circle Clinical Research

    Sioux Falls, South Dakota, 57104, United States

  • Citta Clinical Research, LLC

    Spokane, Washington, 99202, United States

  • Consano Clinical Research

    Shavano Park, Texas, 78231, United States

  • DM Clinical Research

    Indianapolis, Indiana, 46254, United States

  • Denver Endocrinology Diabetes and Thyroid Center

    Englewood, Colorado, 80113, United States

  • Diabetes & Endocrinology Associates of Stark County, Inc

    Canton, Ohio, 44718, United States

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229, United States

  • Excel Clinical Research

    Las Vegas, Nevada, 89109, United States

  • Focus Clinical Research

    West Hills, California, 91307, United States

  • IMAX Clinical Trials

    La Palma, California, 90623, United States

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265, United States

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Javarra Inc.

    Charlotte, North Carolina, 28210, United States

  • John Muir Physician Network Clinical Research Center

    Concord, Ohio, 94520, United States

  • Johnson County Clin-Trials, LLC

    Lenexa, Kansas, 66219, United States

  • Massachusetts General Hospital Diabetes Research Center

    Boston, Massachusetts, 02114, United States

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239, United States

  • Metabolic Research Institute, Inc

    West Palm Beach, Florida, 33413, United States

  • Palm Research Center

    Las Vegas, Nevada, 89128, United States

  • Paradigm Clinical Research

    Boise, Idaho, 83709, United States

  • Paradigm Clinical Research - Modesto

    Modesto, California, 95355, United States

  • Paradigm Clinical Research Centers LLC

    San Diego, California, 92108, United States

  • Physician's East PA

    Greenville, North Carolina, 27834, United States

  • Profound Research LLC

    Farmington Hills, Michigan, 48334, United States

  • SMS Clinical Research LLC

    Mesquite, Texas, 75149, United States

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037, United States

  • Solace Clinical Research

    San Juan, 00907, Puerto Rico

  • Southern Endocrinology Associates PA

    Mesquite, Texas, 75149, United States

  • Tekton Research, LLC

    McKinney, Texas, 75069, United States

  • Texas Diabetes and Endocrinology, P.A

    Austin, Texas, 78731, United States

  • The Jones Center Clinical Research, LLC

    Macon, Georgia, 31210, United States

  • The Lundquist Institute

    Torrance, California, 90502, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Diabetes Institute

    Seattle, Washington, 98109, United States

  • Vector Clinical Trials

    Reno, Nevada, 89511, United States

  • Velocity Clinical Research

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Dallas

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research - Spokane

    Spokane, Washington, 99218, United States

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107, United States

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