A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06131372

Collaborator

(none)

618

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema 2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Type 2 Diabetes Obesity	Drug: Cagrilintide Drug: Semaglutide Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

618 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Semaglutide 2.4 mg, Cagrilintide 2.4 mg and Placebo in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Oct 13, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CagriSema 2.4 mg/2.4 mg Participants will receive 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.	Drug: Cagrilintide Participants will receive Cagrilintide subcutaneously. Drug: Semaglutide Participants will receive semaglutide subcutaneously.
Experimental: Semaglutide 2.4 mg Participants will receive semaglutide 2.4 mg and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.	Drug: Semaglutide Participants will receive semaglutide subcutaneously. Drug: Placebo Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Experimental: Cagrilintide 2.4 mg Participants will receive cagrilintide 2.4 mg and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.	Drug: Cagrilintide Participants will receive Cagrilintide subcutaneously. Drug: Placebo Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Placebo Comparator: Placebo Participants will receive 2.4 mg placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.	Drug: Placebo Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.

Outcome Measures

Primary Outcome Measures

Change in urinary albumin-to-creatinine ratio (UACR) [From baseline (week 0) to end of treatment (week 26)]
Measured in ratio to baseline.

Secondary Outcome Measures

Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021) [From baseline (week 0) to end of treatment (week 26)]
Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m^2).
Change in eGFR (creatinine-based CKD-EPI 2021) [From baseline (week 0) to end of treatment (week 26)]
Measured in mL/min/1.73 m^2.
Relative change in body weight [From baseline (week 0) to end of treatment (week 26)]
Measured in percentage (%).
Achievement of greater than or equal to (≥) 5 % weight reduction [From baseline (week 0) to end of treatment (week 26)]
Count of participants.
Achievement of ≥ 10 % weight reduction [From baseline (week 0) to end of treatment (week 26)]
Count of participants.
Change in waist circumference [From baseline (week 0) to end of treatment (week 26)]
Measured in centimeter (cm).
Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 26)]
Measured in %-points.
Change in systolic blood pressure [From baseline (week 0) to end of treatment (week 26)]
Measured in millimeters of mercury (mmHg).
Change in diastolic blood pressure [From baseline (week 0) to end of treatment (week 26)]
Measured in mmHg.
Number of treatment emergent adverse events (TEAEs) [From baseline (week 0) to end of study (week 32)]
count of events.
Number of treatment emergent serious adverse events (SAEs) [From baseline (week 0) to end of study (week 32)]
count of events.
Number of clinically significant hypoglycaemic episodes (level 2) ( blood glucose less than [<] 3.0 millimoles per liter [mmol/L] (54 milligram per deciliter [mg/dL])) [From baseline (week 0) to end of study (week 32)]
Count of episodes.
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold [From baseline (week 0) to end of study (week 32)]
Count of episodes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female.
Age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening.
HbA1c less than or equal to (≤) 10.5% (91 millimoles per mole [mmol/mol]) as assessed by central laboratory at screening.
Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 milliliters per minutes per 1.73^m2 (mL/min/1.73 m^2) (CKD-EPI 2021) as assessed by central laboratory at screening.
Albuminuria defined by UACR ≥ 100 and < 5000 milligram per gram (mg/g) as assessed by central laboratory at screening.
Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
Use of any glucagon-like peptide-1 receptor agonist (GLP-1RA) (including medication with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to screening.
Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.
Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Concord	California	United States	94520
2	Novo Nordisk Investigational Site	Fresno	California	United States	93720
3	Novo Nordisk Investigational Site	Palm Springs	California	United States	92262
4	Novo Nordisk Investigational Site	San Dimas	California	United States	91773
5	Novo Nordisk Investigational Site	San Ramon	California	United States	94583
6	Novo Nordisk Investigational Site	Fleming Island	Florida	United States	32003
7	Novo Nordisk Investigational Site	Orlando	Florida	United States	32804
8	Novo Nordisk Investigational Site	Flint	Michigan	United States	48532
9	Novo Nordisk Investigational Site	Albany	New York	United States	12208
10	Novo Nordisk Investigational Site	Mineola	New York	United States	11501
11	Novo Nordisk Investigational Site	New York	New York	United States	10016
12	Novo Nordisk Investigational Site	West Seneca	New York	United States	14224
13	Novo Nordisk Investigational Site	Winston-Salem	North Carolina	United States	27103
14	Novo Nordisk Investigational Site	Maumee	Ohio	United States	43537
15	Novo Nordisk Investigational Site	Beaver	Pennsylvania	United States	15009
16	Novo Nordisk Investigational Site	Corpus Christi	Texas	United States	78414
17	Novo Nordisk Investigational Site	Houston	Texas	United States	77099
18	Novo Nordisk Investigational Site	Kenosha	Wisconsin	United States	53144
19	Novo Nordisk Investigational Site	Caba	Buenos Aires	Argentina	C1128 AAF
20	Novo Nordisk Investigational Site	Buenos Aires		Argentina	C1425AGC
21	Novo Nordisk Investigational Site	Mar del Plata		Argentina	B7600GNY
22	Novo Nordisk Investigational Site	Santa Rosa		Argentina	6300
23	Novo Nordisk Investigational Site	Curitiba	Parana	Brazil	80440-020
24	Novo Nordisk Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90430-001
25	Novo Nordisk Investigational Site	São Paulo	Sao Paulo	Brazil	01228-200
26	Novo Nordisk Investigational Site	Sao Paulo		Brazil	04038-002
27	Novo Nordisk Investigational Site	Concord	Ontario	Canada	L4K 4M2
28	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8M 1K7
29	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M5G 2N2
30	Novo Nordisk Investigational Site	Laval	Quebec	Canada	H7T 2P5
31	Novo Nordisk Investigational Site	Ontario		Canada	N7T 4X3
32	Novo Nordisk Investigational Site	Le Creusot		France	71200
33	Novo Nordisk Investigational Site	Paris Cedex 14		France	75674
34	Novo Nordisk Investigational Site	Poitiers		France	86000
35	Novo Nordisk Investigational Site	Reims cedex		France	51092
36	Novo Nordisk Investigational Site	Saint Herblain		France	44800
37	Novo Nordisk Investigational Site	Toulouse Cedex 9		France	31059
38	Novo Nordisk Investigational Site	Athens		Greece	GR-11527
39	Novo Nordisk Investigational Site	Athens		Greece	GR-17562
40	Novo Nordisk Investigational Site	Lamia		Greece	GR35100
41	Novo Nordisk Investigational Site	Larissa		Greece	GR-41110
42	Novo Nordisk Investigational Site	Patra		Greece	GR-26504
43	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54635
44	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54642
45	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-57010
46	Novo Nordisk Investigational Site	Baja	Bács-Kiskun	Hungary	6500
47	Novo Nordisk Investigational Site	Budapest		Hungary	1032
48	Novo Nordisk Investigational Site	Debrecen		Hungary	4025
49	Novo Nordisk Investigational Site	Nyíregyháza		Hungary	4405
50	Novo Nordisk Investigational Site	Pécs		Hungary	7623
51	Novo Nordisk Investigational Site	Siófok		Hungary	8600
52	Novo Nordisk Investigational Site	Bialystok	Podlaskie	Poland	15-481
53	Novo Nordisk Investigational Site	Bialystok		Poland	15-351
54	Novo Nordisk Investigational Site	Gdynia		Poland	81-338
55	Novo Nordisk Investigational Site	Katowice		Poland	40-081
56	Novo Nordisk Investigational Site	Katowice		Poland	40-083
57	Novo Nordisk Investigational Site	Olsztyn		Poland	10-117
58	Novo Nordisk Investigational Site	Poznan		Poland	61-251
59	Novo Nordisk Investigational Site	Warszawa		Poland	02-507
60	Novo Nordisk Investigational Site	Wroclaw		Poland	52-416
61	Novo Nordisk Investigational Site	Bratislava		Slovakia	851 01
62	Novo Nordisk Investigational Site	Kosice		Slovakia	040 01
63	Novo Nordisk Investigational Site	Roznava		Slovakia	048 01
64	Novo Nordisk Investigational Site	Majadahonda	Madrid	Spain	28222
65	Novo Nordisk Investigational Site	Alcorcon		Spain	28922
66	Novo Nordisk Investigational Site	Hospitalet de Llobregat		Spain	08907
67	Novo Nordisk Investigational Site	Santa Cruz de Tenerife		Spain	38320
68	Novo Nordisk Investigational Site	Valencia		Spain	46010
69	Novo Nordisk Investigational Site	Bangkok Noi	Bangkok	Thailand	10700
70	Novo Nordisk Investigational Site	Patumwan	Bangkok	Thailand	10330
71	Novo Nordisk Investigational Site	Chiang Mai	Mueang Chiang Mai District	Thailand	50200
72	Novo Nordisk Investigational Site	Klong Luang	Pathum Thani	Thailand	12120
73	Novo Nordisk Investigational Site	Bangkok		Thailand	10400
74	Novo Nordisk Investigational Site	Bangkok		Thailand	10700