DRUG
UBT251
UBT251 will be administered subcutaneously once-weekly.
Status
Recruiting
Phase
Phase 2
Enrollment
300
Locations
69
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
UBT251 will be administered subcutaneously once-weekly.
DRUG
UBT251 placebo will be administered subcutaneously once-weekly.
DRUG
Semaglutide will be administered subcutaneously once-weekly.
DRUG
Semaglutide placebo will be administered subcutaneously once-weekly.
Timeline
First posted
Jun 25, 2026
Study start
Jun 22, 2026
Primary completion
Oct 4, 2027
Study completion
Nov 15, 2027
Results posted
Not reported
Registry updated
Jul 14, 2026
Outcomes
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)
Measured as percentage (%)-point.
UBT251: Relative change in body weight
Time frame · From baseline (week 0) to week 40
Measured as %.
UBT251: Change in body weight
Time frame · From baseline (week 0) to week 40
Measured as kilogram (kg).
UBT251 vs placebo: Change in HbA1c
Time frame · From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Measured as %-point.
Change in HbA1c
Time frame · From baseline (week 0) to week 40
Measured as %-point.
Change in homeostasis model assessment of insulin resistance (HOMA2-IR)
Time frame · From baseline (week 0) to week 40
Measured as ratio to baseline.
Change in homeostasis model assessment of beta-cell function (HOMA2-B)
Time frame · From baseline (week 0) to week 40
Measured as ratio to baseline.
Change in fasting plasma glucose (FPG)
Time frame · From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Measured as millimoles per litre (mmol/L).
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 milligrams per deciliter (mg/dL))
Time frame · From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively
Measured as %-points.
UBT251 vs placebo: Relative change in body weight
Time frame · From baseline (week 0) to week 40
Measured as %.
UBT251 vs placebo: Change in body weight
Time frame · From baseline (week 0) to week 40
Measured as kg.
Eligibility
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 locations
Australia · Germany · Hungary · Poland · Romania · Slovakia · South Korea · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
Flourish Research
Birmingham, Alabama, United States
Ark Clinical Research
Fountain Valley, California, United States
Ark Clinical Research
Long Beach, California, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Encore Medical Research LLC
Hollywood, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
MD Medical Research
Oxon Hill, Maryland, United States
PharmQuest
Greensboro, North Carolina, United States
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina, United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, United States
Monroe Biomedical Research, LLC
North Charleston, South Carolina, United States
LifeDoc Health
Memphis, Tennessee, United States
IMA Clinical Research
Austin, Texas, United States
Private Practice - Dr. Laila A. Hassan
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Tekton Research Inc
San Antonio, Texas, United States
Consano Clin Res-Shavano Park
Shavano Park, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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