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

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo (matched to NNC0487-0111); Drug: NNC0487-0111

Study type: Interventional

Funder types: Industry

Identifiers

NCT07508020

U1111-1319-9246 (Other Identifier)

NN9490-8151

2025-521393-34 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

NNC0487-0111

Experimental group

Description:

Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly.

Treatment:

Drug: NNC0487-0111

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.

Treatment:

Drug: Placebo (matched to NNC0487-0111)