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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Male or female (sex at birth).

• 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).

• Age at the time of signing the informed consent:

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

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

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

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

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

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

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

• 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.

Locations
United States
California
Altasciences Clinical LA, Inc.
RECRUITING
Cypress
Kansas
Altasciences Clinical Kansas, Inc.
NOT_YET_RECRUITING
Overland Park
Other Locations
Canada
Altasciences Clinical Company, Inc
NOT_YET_RECRUITING
Montreal
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-02-02
Estimated Completion Date: 2027-02-18
Participants
Target number of participants: 333
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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