Recruiting
Phase 2

UBT251

Sponsor:

Novo Nordisk A/S

Code:

NCT07668388

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

UBT251

UBT251 Placebo

Semaglutide

Semaglutide Placebo

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07668388

Start date

Jun 22, 2026

Status verified date

Aug, 2026

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Oct 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UBT251

Participants will receive once weekly UBT251 subcutaneously.

placebo comparator: UBT251 Placebo

Participants will receive once weekly UBT251 placebo subcutaneously.

active comparator: Semaglutide

Participants will receive once weekly semaglutide subcutaneously.

placebo comparator: Semaglutide Placebo

Participants will receive once weekly semaglutide placebo subcutaneously.

Interventions

UBT251

UBT251 will be administered subcutaneously once-weekly.

UBT251 Placebo

UBT251 placebo will be administered subcutaneously once-weekly.

Semaglutide

Semaglutide will be administered subcutaneously once-weekly.

Semaglutide Placebo

Semaglutide placebo will be administered subcutaneously once-weekly.

Primary outcome measure

  • UBT251: Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Flourish Research

Recruiting

Birmingham, Alabama, United States, 35205

Ark Clinical Research

Recruiting

Fountain Valley, California, United States, 92708

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Los Angeles Institute for Metabolic Research

Recruiting

Los Angeles, California, United States, 90015

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

South Broward Research LLC

Recruiting

Miramar, Florida, United States, 33027

Encore Medical Research of Weston

Recruiting

Weston, Florida, United States, 33331

Cotton O'Neil Diabetes & Endocrinology

Recruiting

Topeka, Kansas, United States, 66606

MD Medical Research

Recruiting

Oxon Hill, Maryland, United States, 20745

KDCILM, LLC & Accellacare US, Inc.

Recruiting

Wilmington, North Carolina, United States, 28401

Preferred Primary Care Physicians, Inc.

Recruiting

Uniontown, Pennsylvania, United States, 15401

Monroe Biomedical Research, LLC

Recruiting

North Charleston, South Carolina, United States, 29406

LifeDoc Health

Recruiting

Memphis, Tennessee, United States, 38115

IMA Clinical Research

Recruiting

Austin, Texas, United States, 78745

Private Practice - Dr. Laila A. Hassan

Recruiting

Houston, Texas, United States, 77089

Radiance Clinical Research

Recruiting

Lampasas, Texas, United States, 76550

Quality Research Inc

Recruiting

San Antonio, Texas, United States, 78209

Tekton Research Inc

Recruiting

San Antonio, Texas, United States, 78258

Consano Clin Res-Shavano Park

Recruiting

Shavano Park, Texas, United States, 78231

Chrysalis Clinical Research

Recruiting

St. George, Utah, United States, 84790

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-10.