A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity
- Conditions
- OverweightObesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT07184632
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description NNC0662-0419 NNC0662-0419 Participants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation). Placebo Placebo Participant will be randomized to receive placebo in: The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).
- Primary Outcome Measures
Name Time Method Part A: Number of treatment-emergent adverse events (TEAE) From baseline (week 0) to end of study (up to week 44) Measured as number of events.
Part B: Relative change in body weight From baseline (week 0) to end of treatment (week 36) Measured as percentage (%).
Part C: Occurrence of premature treatment discontinuation (Yes/No) At end of treatment (week 24) Measured as count of participants.
- Secondary Outcome Measures
Name Time Method Part B: Number of treatment emergent adverse events (TEAE) From baseline (week 0) to end of study (week 39) Measured as number of events.
Part C: Number of treatment emergent adverse events (TEAE) From baseline (week 0) to end of study (week 27) Measured as number of events.
Part A: Relative change in body weight From baseline (week 0) to end of treatment (up to week 40) Measured as percentage (%).
Part A: Change in body weight From baseline (week 0) to end of treatment (up to week 40) Measured in kilograms (kg).
Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve From pre-dose on day 1 to completion of the end of study visit (up to week 44) Measured in hours\*nanomole per litre (h\*nmol/L).
Part A: Cmax; the maximum plasma concentration of NNC0662-0419 From pre-dose on day 1 to completion of the end of study visit (up to week 44) Measured in nanomole per litre (nmol/L).
Part B: Change in body weight From baseline (week 0) to end of treatment (week 36) Measured in kg.
Part B: Body weight reduction greater than or equal to (≥) 5% (Yes/No) From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Part B: Body weight reduction ≥ 10% (Yes/No) From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Part B: Body weight reduction ≥ 15% (Yes/No) From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Part B: Body weight reduction ≥ 20% (Yes/No) From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Part B: Body weight reduction ≥ 25% (Yes/No) From baseline (week 0) to end of treatment (week 36) Measured as count of participants.
Trial Locations
- Locations (2)
Celerion, Phoenix
🇺🇸Tempe, Arizona, United States
Celerion, Lincoln
🇺🇸Lincoln, Nebraska, United States
Celerion, Phoenix🇺🇸Tempe, Arizona, United States