RecruitingPhase 2

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

Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well different doses of UBT251 lower blood sugar and how safe it is for adults with type 2 diabetes. People will get UBT251, semaglutide, or a placebo (a treatment with no active medicine), chosen by chance. UBT251 is not yet available for doctors to prescribe, but semaglutide is.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People of all gender identities may join.
  • Be 18 to 75 years old when signing the study consent form.
  • Have been diagnosed with type 2 diabetes at least 180 days before screening.
  • Take metformin, with or without an SGLT2 inhibitor (another diabetes medicine). Daily doses must be unchanged for at least 90 days before screening and judged by the study doctor to work well or be the highest dose you can tolerate.
  • Have an HbA1c of 7.0% to 10.5% at screening. This blood test measures your average blood sugar.
  • Have a body mass index (BMI) of 25 to 50 at screening. BMI is a measure based on height and weight.

Who can't join

  • Used other medicines or alternative remedies for diabetes or obesity within 90 days before screening. Insulin used for up to 14 days in a row, or previously used for diabetes during pregnancy, is allowed.
  • Have diabetes-related eye damage that is not controlled and may be unstable. An eye exam is needed to check this.
  • Have trouble noticing when your blood sugar is too low, as checked by the study doctor using a questionnaire.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 (25)

AL

CA

FL

IN

KS

MD

NC

ND

PA

SC

TN

TX

UT

WA