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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: UBT251; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 333
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Recruiting
      • Altasciences Clinical Company, Inc
• United States
  • California
    • Cypress, California, United States, 90630
      • Recruiting
      • Altasciences Clinical LA, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Recruiting
      • Altasciences Clinical Kansas, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A - Number of treatment emergent adverse events (TEAEs)	Measured as Number of events.	From baseline (week 0) to end of study (week 33)
Part B - Relative change in body weight	Measured as percentage of body weight.	From baseline (week 0) to end of treatment (week 28)
Part C- AUC; the area under the UBT251 plasma concentration time curve	Measured as hour*nanomoles per liter (h*nmol/L)	From pre-dose on Day 1 until completion of the end of study visit (Day 43)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A - Relative change in body weight	Measured as percentage of body weight.	From baseline (week 0) to end of treatment (week 28)
Part A - Change in body weight	Measured as kilogram (kg).	From baseline (week 0) to end of treatment (week 28)
Part A - AUC; the area under the UBT251 plasma concentration-time curve	Measured as h*nmol/L	From pre-dose on day 1 to end of study (week 33)
Part A - Cmax; the maximum plasma concentration of UBT251	Measured as nanomole per liter (nmol/L)	From pre-dose on day 1 to end of study (week 33)
Part B - Change in body weight	Measured as kg.	From baseline (week 0) to end of treatment (week 28)
Part B - Change in waist circumference	Measured as centimetre (cm).	From baseline (week 0) to end of treatment (week 28)
Part B - Number of TEAEs	Measured as number of events	From baseline (week 0) to end of study (week 33)
Part C - Cmax; the maximum plasma concentration of UBT251	Measured as nmol/L	From pre-dose on Day 1 until completion of the end of study visit (Day 43)
Part C - Number of treatment-emergent adverse events (TEAEs)	Measured as number of events.	From pre-dose on Day 1 until completion of the end of study visit (Day 43)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): February 18, 2027

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN9559-8568; U1111-1324-3831 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No