A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.
Overview
- Phase
- Phase 1
- Intervention
- Cagrilintide B
- Conditions
- Obesity
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 177
- Locations
- 1
- Primary Endpoint
- Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening.
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- •Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
- •Impaired liver function defined as any of the below:
- •Aspartate aminotransferase (AST) more than or equal to (\>=) 2 times upper limit of normal at screening
- •Alanine aminotransferase (ALT) more than or equal to (\>=) 2 times upper limit of normal at screening
- •Bilirubin more than (\>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at screening.
- •Glycated haemoglobin (HbA1c) more than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.
- •Any clinically significant body weight change more than or equal to (\>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening .
Arms & Interventions
Part B: Placebo
Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.
Intervention: Cagrilintide B
Part A: NNC0174-1213 (SD1-SD5)
Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.
Intervention: Cagrilintide B
Part A: NNC0174-1213 (SD1-SD5)
Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.
Intervention: Placebo A (NNC0174 1213 A)
Part A: Cagrilintide (SDA and SDB)
Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4.
Intervention: NNC0174-1213 A
Part A: NNC0174-1213 (SD1-SD5)
Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.
Intervention: NNC0174-1213 A
Part A: Cagrilintide (SDA and SDB)
Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4.
Intervention: Cagrilintide B
Part A: Cagrilintide (SDA and SDB)
Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4.
Intervention: Placebo A (NNC0174 1213 A)
Part A: Placebo
Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.
Intervention: NNC0174-1213 A
Part A: Placebo
Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.
Intervention: Cagrilintide B
Part A: Placebo
Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.
Intervention: Placebo A (NNC0174 1213 A)
Part B: NNC0174-1213 (MD1-MD5)
Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.
Intervention: NNC0174-1213 A
Part B: NNC0174-1213 (MD1-MD5)
Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.
Intervention: Cagrilintide B
Part B: NNC0174-1213 (MD1-MD5)
Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.
Intervention: Placebo A (NNC0174 1213 A)
Part B: Cagrilintide (MDA)
Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.
Intervention: NNC0174-1213 A
Part B: Cagrilintide (MDA)
Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.
Intervention: Cagrilintide B
Part B: Cagrilintide (MDA)
Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.
Intervention: Placebo A (NNC0174 1213 A)
Part B: Placebo
Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.
Intervention: NNC0174-1213 A
Part B: Placebo
Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.
Intervention: Placebo A (NNC0174 1213 A)
Outcomes
Primary Outcomes
Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
Time Frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)
Number of events
Part B: Number of treatment emergent adverse events (TEAE)
Time Frame: From first administration (Day 1) to completion of the end of study visit (Day 67)
Number of events
Secondary Outcomes
- Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve(From pre-dose on Day 1 to completion of the end of study visit (Day 46))
- Part A: Cmax; maximum observed NNC0174 1213 plasma concentration(From pre-dose on Day 1 to completion of the end of study visit (Day 46))
- Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve(From first administration (Day 1) to completion of the end of study visit (Day 67))
- Part B: Cmax; maximum observed NNC0174 1213 plasma concentration(From first administration (Day 1) to completion of the end of study visit (Day 67))