Different doses of UBT251 for adults with overweight or obesity

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

This trial will test whether different doses of UBT251 help adults with overweight or obesity by comparing the medicine to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 333 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (industry)
• Locations: 3 sites (Cypress, California and 2 other locations)
• Trial ID: NCT07395687 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, placebo-controlled interventional study testing safety and effectiveness of UBT251 in adults with excess weight. Participants are randomized to receive UBT251 or placebo at clinical sites in California, Kansas, and Quebec. The study is organized into Parts A, B, and C with different age and BMI entry ranges and Part C enrolling self‑reported Japanese, Chinese, or non‑Asian participants as specified. Safety, tolerability, and weight-related measures will be collected during the treatment period to compare outcomes between active drug and placebo.

Who should consider this trial

Good fit: Adults who meet the study's age and BMI windows (Part A: 18–55 years, BMI 27.0–39.9; Part B: 18–65 years, BMI 30.0–50.0; Part C: 18–55 years, BMI 24–34.9) who are medically eligible and, for Part C, self‑identify as Japanese, Chinese, or non‑Asian with both parents of that descent.

Not a fit: People outside the study's specified age or BMI ranges, those with weight caused primarily by other medical conditions, pregnant or breastfeeding people, or those with medical issues that make participation unsafe are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, UBT251 could become an additional medical option to help adults with overweight or obesity lose weight and improve related health measures.

How similar studies have performed: Other pharmaceutical approaches to weight management have shown benefit in prior trials, but UBT251 itself is investigational and has limited public efficacy data to date.

Eligibility criteria

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.

Where this trial is running

Cypress, California and 2 other locations

• Altasciences Clinical LA, Inc. — Cypress, California, United States (RECRUITING)
• Altasciences Clinical Kansas, Inc. — Overland Park, Kansas, United States (RECRUITING)
• Altasciences Clinical Company, Inc — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Novo Nordisk

Conditions: Overweight, Obesity