Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 354
- Locations
- 119
- Primary Endpoint
- Relative change in body weight
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female of non-childbearing potential, or male.
- •a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
- •Age 18-75 years (both inclusive) at the time of signing the informed consent.
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
- •a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
- •b) BMI ≥ 30.0 kg/m2.
Exclusion Criteria
- •HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
Arms & Interventions
Dosing scheme a: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Intervention: Placebo (Drug)
Dosing scheme b: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Intervention: Placebo (Drug)
Dosing scheme c: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Intervention: Placebo (Drug)
Dosing scheme d: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Intervention: Placebo (Drug)
Dosing scheme e: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Intervention: Placebo (Drug)
Dosing scheme f: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Intervention: Placebo (Drug)
Dosing scheme a: NNC0519-0130
Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Intervention: NNC0519-0130 (Drug)
Dosing scheme c: NNC0519-0130
Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Intervention: NNC0519-0130 (Drug)
Dosing scheme d: NNC0519-0130
Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Intervention: NNC0519-0130 (Drug)
Dosing scheme b: NNC0519-0130
Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Intervention: NNC0519-0130 (Drug)
Dosing scheme f: NNC0519-0130
Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Intervention: NNC0519-0130 (Drug)
Dosing scheme e: NNC0519-0130
Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Intervention: NNC0519-0130 (Drug)
Dosing scheme g: Tirzepatide
Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Intervention: Tirzepatide (Drug)
Outcomes
Primary Outcomes
Relative change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 36)
Measured in percentage of body weight.
Secondary Outcomes
- Change in body weight(From baseline (week 0) to end of treatment (week 36))
- Achievement of ≥ 10% weight reduction(From baseline (week 0) to end of treatment (week 36))
- Achievement of ≥ 15% weight reduction(From baseline (week 0) to end of treatment (week 36))
- Achievement of greater than equal to (≥) 5% weight reduction(From baseline (week 0) to end of treatment (week 36))
- Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 36))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 36))
- Change in glycated hemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 36))
- Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 36))
- Achievement of ≥ 20% weight reduction(From baseline (week 0) to end of treatment (week 36))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to end of treatment (week 36))
- Change in high sensitivity C-Reactive protein (hsCRP)(From baseline (week 0) to end of treatment (week 36))
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to end of treatment (week 36))
- Change in total cholesterol(From baseline (week 0) to end of treatment (week 36))
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score(From baseline (week 0) to end of treatment (week 36))
- Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 36))
- Change in triglycerides(From baseline (week 0) to end of treatment (week 36))
- Change in IWQOL-Lite-CT Psychosocial composite score(From baseline (week 0) to end of treatment (week 36))
- Change in IWQOL-Lite-CT Physical Function score(From baseline (week 0) to end of treatment (week 36))
- Number of adverse events(From baseline (week 0) to end of treatment (week 40))
- Change in IWQOL-Lite-CT Total score(From baseline (week 0) to end of treatment (week 36))