Clinical trial

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

Recruiting now · Phase 2 · 2 countries · Registry ID NCT07395687

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity

Full registry 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.

Treatments and study arms

UBT251

Drug

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

Placebo

Drug

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

Primary outcomes

Part A - Number of treatment emergent adverse events (TEAEs)From baseline (week 0) to end of study (week 33)

Measured as Number of events.

Part B - Relative change in body weightFrom baseline (week 0) to end of treatment (week 28)

Measured as percentage of body weight.

Part C- AUC; the area under the UBT251 plasma concentration time curveFrom pre-dose on Day 1 until completion of the end of study visit (Day 43)

Measured as hour\*nanomoles per liter (h\*nmol/L)

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Altasciences Clinical Company, Inc🇨🇦 Montreal, Quebec, Canada
Altasciences Clinical LA, Inc.🇺🇸 Cypress, California, United States
Altasciences Clinical Kansas, Inc.🇺🇸 Overland Park, Kansas, United States