A Research Study Comparing How Well Different Doses of th... | NCT07668388

ID	Type	Description	Link
U1111-1329-7014	Other Identifier	World Health Organization (WHO)
2026-525465-42	Other Identifier	European Medical Agency (EMA)

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2026Estimated

Primary Completion Date

Oct 4, 2027Estimated

Completion Date

Nov 15, 2027Estimated

First Submitted Date

Jun 19, 2026

First Submission Date that Met QC Criteria

Jun 19, 2026

First Posted Date

Jun 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2026

Last Update Posted Date

Jun 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UBT251	Experimental	Participants will receive once weekly UBT251 subcutaneously.	Drug: UBT251
UBT251 Placebo	Placebo Comparator	Participants will receive once weekly UBT251 placebo subcutaneously.	Drug: UBT251 Placebo
Semaglutide	Active Comparator	Participants will receive once weekly semaglutide subcutaneously.	Drug: Semaglutide
Semaglutide Placebo	Placebo Comparator	Participants will receive once weekly semaglutide placebo subcutaneously.	Drug: Semaglutide Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UBT251	Drug	UBT251 will be administered subcutaneously once-weekly.	UBT251

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UBT251: Change in glycated haemoglobin (HbA1c)	Measured as percentage (%)-point.	From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

Secondary Outcomes

Measure	Description	Time Frame
UBT251: Relative change in body weight	Measured as %.	From baseline (week 0) to week 40
UBT251: Change in body weight	Measured as kilogram (kg).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Novo Nordisk	Contact	(+1) 866-867-7178		clinicaltrials@novonordisk.com

Name	Affiliation	Role
Clinical Transparency dept. 2834	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Flourish Research		Birmingham	Alabama	35205	United States
Ark Clinical Research

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://novonordisk-trials.com

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases