Obesity, Overweight
Conditions
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.
Interventions
DRUGUBT251
UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
DRUGPlacebo
Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 weight | From 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 curve | From pre-dose on Day 1 until completion of the end of study visit (Day 43) | Measured as hour\*nanomoles per liter (h\*nmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A - Relative change in body weight | From baseline (week 0) to end of treatment (week 28) | Measured as percentage of body weight. |
| Part A - Change in body weight | From baseline (week 0) to end of treatment (week 28) | Measured as kilogram (kg). |
| Part A - AUC; the area under the UBT251 plasma concentration-time curve | From pre-dose on day 1 to end of study (week 33) | Measured as h\*nmol/L |
| Part A - Cmax; the maximum plasma concentration of UBT251 | From pre-dose on day 1 to end of study (week 33) | Measured as nanomole per liter (nmol/L) |
| Part B - Change in body weight | From baseline (week 0) to end of treatment (week 28) | Measured as kg. |
| Part B - Change in waist circumference | From baseline (week 0) to end of treatment (week 28) | Measured as centimetre (cm). |
| Part B - Number of TEAEs | From baseline (week 0) to end of study (week 33) | Measured as number of events |
| Part C - Cmax; the maximum plasma concentration of UBT251 | From pre-dose on Day 1 until completion of the end of study visit (Day 43) | Measured as nmol/L |
| Part C - Number of treatment-emergent adverse events (TEAEs) | From pre-dose on Day 1 until completion of the end of study visit (Day 43) | Measured as number of events. |
Countries
Canada, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed