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

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (week 24) to end of treatment (week 40)

Summary

This trial is testing a new weight loss medicine where participants receive either a combination of two medicines or one medicine alone. The medicine is given through regular injections using a pre-filled pen. The study targets individuals looking to lose weight, with specific guidelines for women regarding pregnancy and contraception. One of the medicines has been shown to induce significant weight loss in individuals with obesity or overweight, and it is approved for chronic weight management.

Eligible Conditions
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (week 24) to end of treatment (week 40)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (week 24) to end of treatment (week 40) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Number of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Part 2: Change in HbA1c
Part 2: Change in body weight
Part 2: Change in fasting insulin
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 2.4 mg and NNC0165-1875 2.0 mgExperimental Treatment1 Intervention
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Group II: Semaglutide 2.4 mg and NNC0165-1875 1.0 mgExperimental Treatment1 Intervention
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
Group III: Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)Placebo Group1 Intervention
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Group IV: Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)Placebo Group1 Intervention
Participants will receive placebo as an add on to semaglutide 2.4 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
2021
Completed Phase 2
~120
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
2021
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,646,387 Total Patients Enrolled
157 Trials studying Obesity
144,080 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
45,245 Total Patients Enrolled
11 Trials studying Obesity
18,553 Patients Enrolled for Obesity
~27 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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