Dysautonomia International

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

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A - UBT251	Participants will be randomized to receive multiple dose levels subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Placebo Comparator Part A - placebo	Participants will receive placebo matched to UBT251 subcutaneously.	Drug: Placebo Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part B - Arm A (UBT251)	Participants will be randomized to receive multiple dose levels subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part B - Arm B (UBT251)	Participants will be randomized to receive multiple dose levels subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part B - Arm C (UBT251)	Participants will be randomized to receive multiple dose levels subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part B - Arm D (UBT251)	Participants will be randomized to receive 2 dose levels subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part B - Arm E (UBT251)	Participants will be randomized to receive a single dose level subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Placebo Comparator Part B - placebo	Participants will receive placebo matching one of the UBT251 arms subcutaneously.	Drug: Placebo Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part C - UBT251 dose 1	Participants will be randomized to receive dose level 1 subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part C - UBT251 dose 2	Participants will be randomized to receive dose level 2 subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Experimental Part C - UBT251 dose 3	Participants will be randomized to receive dose level 3 subcutaneously.	Drug: UBT251 UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Recruiting Locations

Altasciences Clinical LA, Inc.
Cypress 5341256, California 5332921 90630

More Details

Status: Recruiting
Sponsor: Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.