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

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide 2.4 mg and NNC0165-1875 2.0 mg — DRUG
  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.
• Semaglutide 2.4 mg and placebo 2.0 mg — DRUG
  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.
• Semaglutide 2.4 mg and NNC0165-1875 1.0 mg — DRUG
  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.
• Semaglutide 2.4 mg and placebo 1.0 mg — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 15, 2021

Status verified

Jan 2026

Primary completion

Dec 6, 2022

Completion

Jan 30, 2023

Study Design

Enrollment

120 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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.
• 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
• 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.

Primary Outcome Measure

Part 1: Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Part 1: From time of dosing (day 1) to follow-up (week 24) ]

Locations (25)

Related coverage on Hipa.ai

• Semaglutide Plus NNC0165-1875 Reduces Body Weight in Obesity Study
  Semaglutide · Jan 8, 2026 · ClinicalTrials.gov

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