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

NCT07395687 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: NN9559-8568U1111-1324-3831
• Study Type: interventional
• Target: 333
• Locations: 2 countries
• Sites: 3

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

Obesity; Overweight

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Part A - Relative change in body weight

  From baseline (week 0) to end of treatment (week 28)

• Part A - Change in body weight

  From baseline (week 0) to end of treatment (week 28)

• Part A - AUC; the area under the UBT251 plasma concentration-time curve

  From pre-dose on day 1 to end of study (week 33)

• Part A - Cmax; the maximum plasma concentration of UBT251

  From pre-dose on day 1 to end of study (week 33)

• Part B - Change in body weight

  From baseline (week 0) to end of treatment (week 28)

Study Arms (11)

Part A - UBT251

EXPERIMENTAL

Participants will be randomized to receive multiple dose levels subcutaneously.

Drug: UBT251

Part A - placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to UBT251 subcutaneously.

Drug: Placebo

Part B - Arm A (UBT251)

EXPERIMENTAL

Participants will be randomized to receive multiple dose levels subcutaneously.

Drug: UBT251

Part B - Arm B (UBT251)

EXPERIMENTAL

Participants will be randomized to receive multiple dose levels subcutaneously.

Drug: UBT251

Part B - Arm C (UBT251)

EXPERIMENTAL

Participants will be randomized to receive multiple dose levels subcutaneously.

Drug: UBT251

Part B - Arm D (UBT251)

EXPERIMENTAL

Participants will be randomized to receive 2 dose levels subcutaneously.

Drug: UBT251

Part B - Arm E (UBT251)

EXPERIMENTAL

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

Drug: UBT251

Part B - placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part C - UBT251 dose 1

EXPERIMENTAL

Participants will be randomized to receive dose level 1 subcutaneously.

Drug: UBT251

Part C - UBT251 dose 2

EXPERIMENTAL

Participants will be randomized to receive dose level 2 subcutaneously.

Drug: UBT251

Part C - UBT251 dose 3

EXPERIMENTAL

Participants will be randomized to receive dose level 3 subcutaneously.

Drug: UBT251

Interventions

UBT251 DRUG

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

Part A - UBT251; Part B - Arm A (UBT251); Part B - Arm B (UBT251); Part B - Arm C (UBT251); Part B - Arm D (UBT251); Part B - Arm E (UBT251); Part C - UBT251 dose 1; Part C - UBT251 dose 2; Part C - UBT251 dose 3

Placebo DRUG

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

Part A - placebo; Part B - placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• 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.
• Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

RECRUITING

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

RECRUITING

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): February 18, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (2)