Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07508020

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

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.

Treatments and study arms

NNC0487-0111

Drug

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.

Primary outcomes

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

Measured as percentage change of energy.

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

Measured as percentage change of energy.

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

Measured as percentage change of energy.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Parexel International GmbH🇩🇪 Berlin, Germany