A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity

Phase 1Not Yet RecruitingNCT07508020

Novo Nordisk A/S120 enrolled

Overview

The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Obesity

Interventions

NNC0487-0111DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

Placebo (matched to NNC0487-0111)DRUG

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Male or female (sex at birth). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * Overweight should be due to excess adipose tissue, as judged by the investigator. Key Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * History of type 1 or type 2 diabetes mellitus. * Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) at screening. * Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues. * Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Locations (1)

Parexel International GmbH

Berlin, Germany

Outcomes

Primary Outcomes

Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126

Measured as percentage change of energy.

Time frame: From Baseline to Day 126

Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182

Measured as percentage change of energy.

Time frame: From Baseline to Day 182

Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238

Measured as percentage change of energy.

Time frame: From Baseline to Day 238

Secondary Outcomes

Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126

Measured as kilojoules (kJ).

Time frame: From Baseline to Day 126

Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182

Measured as kJ.

Time frame: From Baseline to Day 182

Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238

Measured as kJ.

Time frame: From Baseline to Day 238

Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126

Measured as grams.

Time frame: From Baseline to Day 126

Central Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Data from ClinicalTrials.gov

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