GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT07395687

RecruitingPhase 2

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity

A Study Investigating Safety, Tolerability and Efficacy of UBT251 in Participants Living With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

UBT251

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Enrollment

333

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Part A - Number of treatment emergent adverse events (TEAEs)•Part B - Relative change in body weight•Part C- AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07395687

Org study IDNN9559-8568

Secondary IDU1111-1324-3831World Health Organization (WHO)

Timeline

Milestones

Study start2026-02-02actual

Study first posted2026-02-09actual

Last update posted2026-04-21actual

Primary completion2027-01-14estimated

Study completion2027-02-18estimated

Assets

Investigational agents

UBT251

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Male or female (sex at birth).

2. For Part C: Japanese, Chinese or non-Asian participants (all self-reported):

–For Japanese participants: both parents of Japanese descent.

–For Chinese participants: both parents of Chinese descent.

–For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).

3. Age at the time of signing the informed consent:

1. For Part A: 18-55 years (both inclusive)

2. For Part B: 18-65 years (both inclusive)

3. For Part C: 18-55 years (both inclusive).

4. BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator):

1. For Part A: 27.0-39.9 kilogram per meter square (kg/m^2) (both inclusive)

2. For Part B: 30.0-50.0 kg/m^2 (both inclusive)

3. For Part C: 24-34.9 kg/m^2 (both inclusive)

5. Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

1. Known or suspected hypersensitivity to study intervention(s) or related products.

2. Treatment with any marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or glucagon receptor agonism within 90 days before screening.

3. Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

5 endpoints

Primary/protocol endpoint

Part B - Relative change in body weight