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Spartanburg Medical Research | Spartanburg, SC

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A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

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Novo Nordisk

Status and phase

Enrolling
Phase 2

Conditions

Obesity

Treatments

Drug: Placebo
Drug: Tirzepatide
Drug: NNC0519-0130

Study type

Interventional

Funder types

Industry

Identifiers

NCT06326060
U1111-1291-9210 (Other Identifier)
NN9541-5015
jRCT2051230198 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

343 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

343 participants in 13 patient groups, including a placebo group

Dosing scheme a: NNC0519-0130
Experimental group
Description:
Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Treatment:
Drug: NNC0519-0130
Dosing scheme a: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment:
Drug: Placebo
Dosing scheme b: NNC0519-0130
Experimental group
Description:
Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Treatment:
Drug: NNC0519-0130
Dosing scheme b: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment:
Drug: Placebo
Dosing scheme c: NNC0519-0130
Experimental group
Description:
Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Treatment:
Drug: NNC0519-0130
Dosing scheme c: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment:
Drug: Placebo
Dosing scheme d: NNC0519-0130
Experimental group
Description:
Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Treatment:
Drug: NNC0519-0130
Dosing scheme d: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment:
Drug: Placebo
Dosing scheme e: NNC0519-0130
Experimental group
Description:
Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Treatment:
Drug: NNC0519-0130
Dosing scheme e: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment:
Drug: Placebo
Dosing scheme f: NNC0519-0130
Experimental group
Description:
Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Treatment:
Drug: NNC0519-0130
Dosing scheme f: Placebo
Placebo Comparator group
Description:
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment:
Drug: Placebo
Dosing scheme g: Tirzepatide
Active Comparator group
Description:
Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Treatment:
Drug: Tirzepatide

Trial contacts and locations

52

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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