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NNC0519-0130 for Kidney Disease

Phase 2

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

HbA1c of 6.5 percentage (%)-10.5 percentage (%) [48 - 91 millimoles per mole (mmol/mol)] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (<)6.5 percentage (%) [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus

Must not have

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency

Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called NNC0519-0130 to see if it is safe and can improve kidney function in people with chronic kidney disease and overweight or obesity, with or without

Who is the study for?

This trial is for people with chronic kidney disease, which may or may not be accompanied by type 2 diabetes. Participants should also be living with overweight or obesity. The study excludes individuals who don't meet the specific health criteria set by the researchers.

What is being tested?

The study tests different doses of a new medicine called NNC0519-0130 against semaglutide (an existing medication) and a placebo to see how well they can reduce kidney damage in patients over a period of up to 43 weeks.

What are the potential side effects?

Possible side effects include reactions typical for medications affecting blood sugar levels and kidney function, such as nausea, vomiting, dizziness, risk of low blood sugar events, and potential impact on kidney-related lab values.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using or willing to use effective birth control methods during the study.

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My HbA1c level is within the required range for my diabetes status.

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I am either a male or a female who cannot become pregnant.

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I am 18 years old or older.

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My kidney function is reduced but not severely impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.

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I haven't had cancer, except for certain skin, low-risk prostate, or in-situ cervical cancers, in the last 5 years.

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I have lupus affecting my kidneys or a condition called ANCA-associated vasculitis.

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I have been on immunosuppressive therapy for kidney disease within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in urinary albumin-to-creatinine ratio (UACR) at week 12

Change in urinary albumin-to-creatinine ratio (UACR) at week 24

Change in urinary albumin-to-creatinine ratio (UACR) at week 36

Secondary study objectives

Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction

Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction

Change in diastolic blood pressure

+7 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Dosing scheme d: NNC0519-0130Experimental Treatment1 Intervention

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group II: Dosing scheme c: NNC0519-0130Experimental Treatment1 Intervention

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group III: Dosing scheme b: NNC0519-0130Experimental Treatment1 Intervention

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group IV: Dosing scheme a: NNC0519-0130Experimental Treatment1 Intervention

Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group V: Dosing scheme e: SemaglutideActive Control1 Intervention

Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.

Group VI: Dosing scheme a: PlaceboPlacebo Group1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Group VII: Dosing scheme b: PlaceboPlacebo Group1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Group VIII: Dosing scheme c: PlaceboPlacebo Group1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Group IX: Dosing scheme d: PlaceboPlacebo Group1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Treatment

First Studied