Recruiting
Phase 2

UBT251

Sponsor:

Novo Nordisk A/S

Code:

NCT07395687

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

UBT251

Placebo

Study Details

Brief summary:

The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.

Conditions

Overweight

Obesity

Study ID

NCT07395687

Start date

Feb 2, 2026

Status verified date

Apr, 2026

Completion date

Feb 18, 2027

Anticipated

Primary completion date

Jan 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not 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.

Study Design

Enrollment

333 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - UBT251

Participants will be randomized to receive multiple dose levels subcutaneously.

placebo comparator: Part A - placebo

Participants will receive placebo matched to UBT251 subcutaneously.

experimental: Part B - Arm A (UBT251)

Participants will be randomized to receive multiple dose levels subcutaneously.

experimental: Part B - Arm B (UBT251)

Participants will be randomized to receive multiple dose levels subcutaneously.

experimental: Part B - Arm C (UBT251)

Participants will be randomized to receive multiple dose levels subcutaneously.

experimental: Part B - Arm D (UBT251)

Participants will be randomized to receive 2 dose levels subcutaneously.

experimental: Part B - Arm E (UBT251)

Participants will be randomized to receive a single dose level subcutaneously.

placebo comparator: Part B - placebo

Participants will receive placebo matching one of the UBT251 arms subcutaneously.

experimental: Part C - UBT251 dose 1

Participants will be randomized to receive dose level 1 subcutaneously.

experimental: Part C - UBT251 dose 2

Participants will be randomized to receive dose level 2 subcutaneously.

experimental: Part C - UBT251 dose 3

Participants will be randomized to receive dose level 3 subcutaneously.

Interventions

UBT251

UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Placebo

Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Primary outcome measure

  • Part A - Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to end of study (week 33) ]
  • Part B - Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 28) ]
  • Part C- AUC; the area under the UBT251 plasma concentration time curve [ Time Frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43) ]

Central Contacts and Locations

Locations

Altasciences Clinical LA, Inc.

Recruiting

Cypress, California, United States, 90630

Altasciences Clinical Kansas, Inc.

Recruiting

Overland Park, Kansas, United States, 66212

Altasciences Clinical Company, Inc

Recruiting

Montreal, Quebec, Canada, H3P 3P1

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-04-21.