A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
Part of paid clinical trials in Mesa, Arizona.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT06326060
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- NNC0519-0130 — DRUGNNC0519-0130 will be administered subcutaneously.
- Placebo — DRUGPlacebo will be administered subcutaneously.
- Tirzepatide — DRUGTirzepatide will be administered subcutaneously.
Study Details
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
Key Dates
- Start date
- Mar 18, 2024
- Status verified
- Apr 2026
- Primary completion
- Apr 10, 2025
- Completion
- May 1, 2025
Study Design
- Enrollment
- 354 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dosing scheme a: NNC0519-0130Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
- Placebo Comparator: Dosing scheme a: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
- Experimental: Dosing scheme b: NNC0519-0130Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
- Placebo Comparator: Dosing scheme b: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
- Experimental: Dosing scheme c: NNC0519-0130Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
- Placebo Comparator: Dosing scheme c: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
- Experimental: Dosing scheme d: NNC0519-0130Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
- Placebo Comparator: Dosing scheme d: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
- Experimental: Dosing scheme e: NNC0519-0130Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
- Placebo Comparator: Dosing scheme e: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
- Experimental: Dosing scheme f: NNC0519-0130Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
- Placebo Comparator: Dosing scheme f: PlaceboParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
- Active Comparator: Dosing scheme g: TirzepatideParticipants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Primary Outcome Measure
Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 36) ]
Locations (49)
Find similar trials in Mesa, AZ
By condition
By specialty
Related Studies
- Diabetes and Heart Disease Risk in BlacksRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Physical and Behavioral Traits of Overweight and Obese AdultsRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss TreatmentPHASE2 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phoenix, Arizona
- Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular SystemRecruiting · National Heart, Lung, and Blood Institute (NHLBI) · Washington D.C., District of Columbia