Current partner codePEPTIDESDE
NCT07668388·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

300

Locations

69

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

UBT251

UBT251 will be administered subcutaneously once-weekly.

DRUG

UBT251 Placebo

UBT251 placebo will be administered subcutaneously once-weekly.

DRUG

Semaglutide

Semaglutide will be administered subcutaneously once-weekly.

DRUG

Semaglutide Placebo

Semaglutide placebo will be administered subcutaneously once-weekly.

Timeline

From registration to results.

  1. First posted

    Jun 25, 2026

  2. Study start

    Jun 22, 2026

  3. Primary completion

    Oct 4, 2027

  4. Study completion

    Nov 15, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 14, 2026

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

69 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.