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HomeTrials › NCT07668388

Type 2 diabetes · Phase 2 · Recruiting now

A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes

NCT07668388 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is recruiting now at 25 US sites. It's studying UBT251, UBT251 Placebo, Semaglutide, Semaglutide Placebo for diabetes mellitus, type 2.

Who can joinAll sexes, 18 Years – 75 Years
Healthy volunteersNo, diagnosis required
What you'd takeUBT251, UBT251 Placebo, Semaglutide, Semaglutide Placebo
Study length~15 months overall
Planned participants300
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18-75 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening. * Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor. * HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening. * Body mass index between 25.0 kg/m\^2 and 50.0 kg/m\^2 (both inclusive) at screening. Exclusion Criteria: * Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.

Study sites by state

Alabama

  • Flourish Research, Birmingham · Recruiting now

California

  • Ark Clinical Research, Fountain Valley · Recruiting now
  • Ark Clinical Research, Long Beach · Recruiting now
  • Los Angeles Institute for Metabolic Research, Los Angeles · Recruiting now
  • Catalina Research Institute, LLC, Montclair · Recruiting now

Florida

  • Encore Medical Research LLC, Hollywood · Recruiting now
  • South Broward Research LLC, Miramar · Recruiting now
  • Encore Medical Research of Weston, Weston · Recruiting now

Indiana

  • Midwest Inst For Clin Res, Indianapolis · Opening soon

Kansas

  • Cotton O'Neil Diabetes & Endocrinology, Topeka · Recruiting now

Maryland

  • MD Medical Research, Oxon Hill · Recruiting now

North Carolina

  • PharmQuest, Greensboro · Opening soon
  • KDCILM, LLC & Accellacare US, Inc., Wilmington · Recruiting now

North Dakota

  • Plains Clinical Research Center, LLC_Fargo, Fargo · Opening soon

Pennsylvania

  • Preferred Primary Care Physicians, Inc., Uniontown · Recruiting now

South Carolina

  • Monroe Biomedical Research, LLC, North Charleston · Recruiting now

Tennessee

  • LifeDoc Health, Memphis · Recruiting now

Texas

  • IMA Clinical Research, Austin · Recruiting now
  • Private Practice - Dr. Laila A. Hassan, Houston · Recruiting now
  • Radiance Clinical Research, Lampasas · Recruiting now
  • Quality Research Inc, San Antonio · Recruiting now
  • Tekton Research Inc, San Antonio · Recruiting now
  • Consano Clin Res-Shavano Park, Shavano Park · Recruiting now

Utah

  • Chrysalis Clinical Research, St. George · Recruiting now

Washington

  • The Vancouver Clinic, Vancouver · Opening soon

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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