Testing different doses of UBT251 to lower blood sugar in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating multiple doses of UBT251 in adults with type 2 diabetes. Participants are randomized to receive UBT251, UBT251 placebo, semaglutide, or semaglutide placebo, to see which regimens best control blood sugar and how safe they are. Eligibility includes adults 18–75 with type 2 diabetes for at least 6 months, a stable background diabetes treatment, and an HbA1c between 7.0% and 10.5%. The study compares the new drug to placebo and includes an active comparator to gauge relative effect.

Why it matters

Who can join: the full rules

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.

Where it's running

• Flourish Research
  Birmingham, Alabama, United States Recruiting
• Ark Clinical Research
  Fountain Valley, California, United States Recruiting
• Ark Clinical Research
  Long Beach, California, United States Recruiting
• Los Angeles Institute for Metabolic Research
  Los Angeles, California, United States Recruiting
• Catalina Research Institute, LLC
  Montclair, California, United States Recruiting
• Encore Medical Research LLC
  Hollywood, Florida, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.