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Efficacy, safety and dose‑response of once‑weekly subcutaneous UBT251 compared with semaglutide in adults with type 2 diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Type 2 diabetes, a condition where the body does not use insulin properly, leading to high blood sugar. It compares a new medicine called UBT251 given by subcutaneous injection once a week with an existing drug, semaglutide, and with a placebo.

The purpose of the study is to determine the dose‑response relationship of UBT251, meaning how different amounts of the medicine change the level of HbA1c, a test that shows average blood sugar over the past few months, in people whose diabetes is not well controlled with metformin alone or together with a SGLT2 inhibitor.

Participants will receive weekly injections for about ten months and will attend regular clinic visits where blood samples are taken and body measurements are recorded. Some participants will receive the new drug, some will receive the existing drug, and some will receive the inactive substance. The study will track changes in blood sugar, weight, and other health markers over the course of the trial.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and baseline assessments
You attend the clinic for the first time (week 0). during this visit a series of measurements are taken, including a blood test called hba1c that shows your average blood sugar over the past few months, weight, blood pressure, and other routine labs.
You also receive information about the study drugs and are asked to sign consent forms that allow you to receive the assigned medication.
Step 2
Randomization and first injection
After the baseline visit you are randomly assigned to receive either ubt251 at a study‑determined dose, the comparator drug semaglutide (0.5 mg) or a matching placebo.
The first dose is given as a subcutaneous injection, which means the medication is placed just under the skin using a pre‑filled pen or syringe.
Step 3
Weekly injections (weeks 1‑12)
You self‑administer, or have a nurse administer, a single injection of the assigned study medication once every week. the injection is performed under the skin (subcutaneous) and the dose remains the same each week during this early period.
If you are assigned to semaglutide, the dose is 0.5 mg per injection. if you are assigned to ubt251, the exact amount is set by the study protocol and is also given once weekly. the placebo looks identical but contains no active drug.
Step 4
Early follow‑up visits (weeks 2, 4, 8, 12)
You return to the clinic at weeks 2, 4, 8 and 12 for safety checks. during each visit blood samples are taken to monitor hba1c, fasting plasma glucose, kidney function, and other safety parameters.
Any side effects or concerns are recorded, and the study team confirms that you are continuing the weekly injections correctly.
Step 5
Dose‑finding period ends and maintenance dose set
Based on the data collected up to week 12, the study determines a maintenance dose of ubt251 for each participant who receives the active drug. from week 13 onward you continue to receive the same weekly injection, now at the maintenance dose.
Participants receiving semaglutide or placebo continue with the same weekly dose they have been using.
Step 6
Mid‑study visits and continued weekly injections (weeks 16 and 28)
At week 16 and again at week 28 you attend a clinic visit where the primary effectiveness measure – the change in hba1c from the start of the maintenance dose – is evaluated.
Additional measurements such as body weight, blood pressure, and laboratory tests are repeated to track any changes.
Step 7
Final visit and end of treatment (week 40)
The last clinic visit occurs at week 40. during this visit a complete set of assessments is performed, including the final hba1c measurement, weight, waist circumference, cholesterol panel, kidney function, and any remaining safety labs.
You receive a final injection of the study medication (or placebo) and the study drug is discontinued after this visit.

Who can join the trial?

6 criteria

You must be male or female (sex assigned at birth), and all gender identities are accepted.
Your age must be between 18 and 75 years when you sign the consent form.
You need to have been diagnosed with type 2 diabetes at least 180 days (about 6 months) before the screening visit.
You must have been taking a stable daily dose of metformin, with or without a SGLT2 inhibitor, for at least 90 days before screening, at a dose that works for you or is the highest you can tolerate.
Your glycated haemoglobin (HbA1c) level—a blood test that shows average blood sugar over the past 2‑3 months—must be between 7.0 % and 10.5 % (53‑91 mmol/mol) when measured at screening.
Your body mass index (BMI)—a calculation using your weight and height—must be between 25.0 and 50.0 kg/m² at screening.

Who cannot join the trial?

3 criteria

Using any medicine (prescription, over‑the‑counter, or herbal) for diabetes or obesity that is not listed in the study’s allowed treatments within 90 days before screening will exclude you; short‑term insulin use for up to 14 days or insulin taken only during pregnancy for gestational diabetes is allowed.
Having uncontrolled or possibly worsening diabetic retinopathy (damage to the blood vessels in the eye) or maculopathy (damage to the central part of the retina) confirmed by an eye exam performed within 90 days before screening or between screening and randomisation will exclude you. The eye exam must include pupil‑dilation with eye drops unless a special non‑dilated camera called a digital fundus photography system is used.
Having hypoglycaemic unawareness—meaning you do not notice symptoms of low blood sugar—according to the investigator’s assessment using question 8 of the Clarke questionnaire will exclude you.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CRS Clinical Research Services Mannheim GmbH
Verified
Mannheim, Germany
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Responsive
Bad Oeynhausen, Germany
Semmelweis University
Responsive
Budapest, Hungary

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Investigated drugs

UBT251
is an investigational medication being tested for people with type 2 diabetes. It is given as a subcutaneous (under the skin) injection once a week. In this study the drug is examined to see how well it can lower the blood‑sugar marker HbA1c over 12 weeks and to understand how different amounts of the drug affect the result.
Ozempic (semaglutide)
is a brand‑name, once‑weekly injectable drug that is already approved for type 2 diabetes. It works by mimicking a natural hormone that helps the body control blood sugar and can also support weight loss. In this trial it is used as the active comparator so researchers can compare the new drug, UBT251, with a proven treatment.

Semaglutide

What is already known about the treatment

UBT251
This medication is given as a subcutaneous injection in a liquid solution, meaning it is injected under the skin using a small needle. It is currently an investigational drug being studied in clinical trials and is not yet approved for routine medical use. UBT251 is being tested for the treatment of type 2 diabetes, aiming to lower blood sugar levels. It works as a novel peptide that activates the GLP‑1 receptor, helping the pancreas release more insulin after meals, and it is classified as an experimental GLP‑1 receptor agonist.
Semaglutide
Semaglutide is administered once weekly as a subcutaneous injection using a pre‑filled pen that delivers a liquid solution under the skin. It is an approved medication that is widely described in medical literature for the management of type 2 diabetes. The drug lowers blood sugar by mimicking the natural hormone GLP‑1, which increases insulin secretion, reduces glucagon release, and slows stomach emptying after eating. It belongs to the pharmacological class of glucagon‑like peptide‑1 (GLP‑1) receptor agonists.

Investigated diseases

Type 2 diabetes mellitus - It is a long‑term condition in which the body does not use insulin effectively, leading to elevated blood glucose levels. Over time the pancreas produces less insulin as the cells that make it become exhausted. The persistent high sugar can gradually affect many parts of the body, such as the blood vessels, nerves and kidneys. The disease often develops slowly and may be unnoticed for years before blood tests reveal abnormal glucose. Lifestyle factors such as excess weight and inactivity increase the risk of developing it. Ongoing monitoring of blood sugar, weight and related health measures is typical in managing the condition.