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

Novo Nordisk

Status and phase: Active, not recruiting; 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: 355 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

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355 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