Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04982575
• Collaborator: (none)
• Enrollment: 90
• Locations: 18
• Arms: 3
• Anticipated Duration (Months): 11
• Patients Per Site: 5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.

Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.

Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.

A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.

Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.

The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.

At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).

Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Semaglutide 2.4 mg; Drug: Cagrilintide 2.4 mg; Drug: Placebo (semaglutide); Drug: Placebo (cagrilintide)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 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-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes
• Actual Study Start Date: Aug 2, 2021
• Anticipated Primary Completion Date: May 23, 2022
• Anticipated Study Completion Date: Jul 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cagrilintide 2.4 mg and semaglutide 2.4 mg Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.	Drug: Semaglutide 2.4 mg; Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks; Drug: Cagrilintide 2.4 mg; Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Active Comparator: Cagrilintide 2.4 mg and placebo (semaglutide) Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks	Drug: Cagrilintide 2.4 mg; Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks; Drug: Placebo (semaglutide); Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Active Comparator: Semaglutide 2.4 mg and Placebo (cagrilintide) Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks	Drug: Semaglutide 2.4 mg; Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks; Drug: Placebo (cagrilintide); Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks

Outcome Measures

Primary Outcome Measures

1. Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to week 32]

   percent-point

Secondary Outcome Measures

1. Change in fasting plasma glucose (FPG) [From baseline (week 0) to week 32]

   mmol/L

2. Change in fasting plasma glucose (FPG) [From baseline (week 0) to week 32]

   mg/dL

3. CGM: Change in mean glucose [From baseline (week 0) to week 32]

   mmol/L

4. CGM: Change in mean glucose [From baseline (week 0) to week 32]

   mg/dL

5. CGM: Time above range (TAR) greater than 10.0 mmol/L (greater than 180 mg/dL) [At week 32]

   percent of readings

6. CGM: Time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) [At week 32]

   percent of readings

7. Change in body weight [From baseline (week 0) to week 32]

   percent

8. Change in body weight [From baseline (week 0) to week 32]

   Kg

9. Number of treatment emergent adverse events (TEAEs) [From baseline (week 0) to week 37]

   Count

10. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0mmol/L (54mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [From baseline (week 0) to week 37]

    Count of episodes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female of non-childbearing potential or male

• Age above or equal to 18 years at the time of signing informed consent

• Body mass index (BMI) greater than or equal to 27.0 kg/m^2

• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening

• Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening

• Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor

Exclusion Criteria:

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed

• Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m^2 by central laboratory at 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35294
2	Novo Nordisk Investigational Site	Los Alamitos	California	United States	90720
3	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
4	Novo Nordisk Investigational Site	Spring Valley	California	United States	91978
5	Novo Nordisk Investigational Site	Golden	Colorado	United States	80401
6	Novo Nordisk Investigational Site	Orlando	Florida	United States	32825
7	Novo Nordisk Investigational Site	Plantation	Florida	United States	33324
8	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
9	Novo Nordisk Investigational Site	Carlinville	Illinois	United States	62626
10	Novo Nordisk Investigational Site	Oxon Hill	Maryland	United States	20745
11	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
12	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
13	Novo Nordisk Investigational Site	Fargo	North Dakota	United States	58104
14	Novo Nordisk Investigational Site	Kingsport	Tennessee	United States	37660
15	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
16	Novo Nordisk Investigational Site	Houston	Texas	United States	77079
17	Novo Nordisk Investigational Site	Longview	Texas	United States	75605
18	Novo Nordisk Investigational Site	Olympia	Washington	United States	98502

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04982575
• Other Study ID Numbers: NN9838-4862
• First Posted: Jul 29, 2021
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 15, 2022