A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04969939
• Collaborator: (none)
• Enrollment: 114
• Locations: 14
• Arms: 4
• Anticipated Duration (Months): 16.2
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; Drug: Semaglutide 2.4 mg and placebo 2.0 mg; Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; Drug: Semaglutide 2.4 mg and placebo 1.0 mg	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• Official Title: Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
• Actual Study Start Date: Jul 15, 2021
• Anticipated Primary Completion Date: May 18, 2022
• Anticipated Study Completion Date: Nov 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg	Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Placebo Comparator: Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg) Participants will receive placebo as an add on to semaglutide 2.4 mg.	Drug: Semaglutide 2.4 mg and placebo 2.0 mg; NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Experimental: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg	Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Placebo Comparator: Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg) Participants will receive placebo as an add on to semaglutide 2.4 mg.	Drug: Semaglutide 2.4 mg and placebo 1.0 mg; NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Outcome Measures

Primary Outcome Measures

1. Part 1: Number of treatment-emergent adverse events (TEAEs) [From time of dosing (day 1) to follow-up (week 24)]

   Number of events

2. Part 2: Change in body weight [From randomisation (week 24) to end of treatment (week 40)]

   Percentage

Secondary Outcome Measures

1. Part 2: Change in body weight [From randomisation (week 24) to end of treatment (week 40)]

   kg

2. Part 2: Change in HbA1c [From randomisation (week 24) to end of treatment (week 40)]

   Percentage point

3. Part 2: Change in fasting plasma glucose [From randomisation (week 24) to end of treatment (week 40)]

   mmol/l

4. Part 2: Change in fasting insulin [From randomisation (week 24) to end of treatment (week 40)]

   pmol/l

5. Part 2: Change in waist circumference [From randomisation (week 24) to end of treatment (week 40)]

   cm

6. Part 2: Relative change in total cholesterol [From randomisation (week 24) to end of treatment (week 40)]

   ratio to baseline

7. Part 2: Relative change in HDL cholesterol [From randomisation (week 24) to end of treatment (week 40)]

   ratio to baseline

8. Part 2: Relative change in LDL cholesterol [From randomisation (week 24) to end of treatment (week 40)]

   ratio to baseline

9. Part 2: Relative change in VLDL cholesterol [From randomisation (week 24) to end of treatment (week 40)]

   ratio to baseline

10. Part 2: Relative change in Triglycerides [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

11. Part 2: Relative change in Free fatty acids [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

12. Part 2: Number of emergent adverse events (TEAEs) [From baseline at (week 0) to end of trial (week 48)]

    Count of events

13. Part 2: Number of serious treatment emergent adverse events (SAEs) [From baseline at (week 0) to end of trial (week 48)]

    Count of events

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

• Male or female, age above or equal to 18 years at the time of signing informed consent.

• BMI 30.0 - 45.0 kg/m^2 (both inclusive) at the screening visit.

Exclusion Criteria:

• HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.

• History of type 1 or type 2 diabetes mellitus.

• Treatment with glucose-lowering agent(s) within 90 days before screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
2	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
3	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
4	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
5	Novo Nordisk Investigational Site	Evanston	Illinois	United States	60201-2477
6	Novo Nordisk Investigational Site	Overland Park	Kansas	United States	66212
7	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40213
8	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
9	Novo Nordisk Investigational Site	Charleston	South Carolina	United States	29425
10	Novo Nordisk Investigational Site	North Charleston	South Carolina	United States	29405
11	Novo Nordisk Investigational Site	Dallas	Texas	United States	75226
12	Novo Nordisk Investigational Site	Saint George	Utah	United States	84790
13	Novo Nordisk Investigational Site	Newport News	Virginia	United States	23606
14	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23294

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: NCT04969939
• Other Study ID Numbers: NN9775-4708; U1111-1254-9046
• First Posted: Jul 21, 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: Obesity

Study Results

No Results Posted as of Mar 15, 2022