A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

Phase 1RecruitingNCT07557953

Novo Nordisk A/S120 enrolled

Overview

The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Overweight Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female (sex at birth). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally healthy, except for overweight or obesity, 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. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening. * History of type 1 or type 2 diabetes mellitus * Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening. * Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues. * Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening. * Previous dosing of marketed or non-marketed amylin-based compounds.

Outcomes

Primary Outcomes

Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box

Measured in percentage (%).

Time frame: From baseline (Day 2) to end of treatment (Day 127)

Secondary Outcomes

Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box

Measured in kilojoule (kJ).

Time frame: From baseline (Day 2) to end of treatment (Day 127)

Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box

Measured in grams (g).

Time frame: From baseline (Day 2) to end of treatment (Day 127)

Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box

Measured in kJ.

Time frame: From baseline (Day 2) to end of treatment (Day 127)

Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)

Measured in millimetre(mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.

Time frame: From baseline (Day 1) to end of treatment (Day 126)

Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption

Measured in mm. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.

Time frame: From baseline (Day 1) to end of treatment (Day 126)

Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness

Measured in mm. VAS appeal questions record the participant's sensations within taste, visual appearance and overall pleasantness by the participants on a paper printed scale line from 0 to 100 mm. Scores of 0 mm are worst and scores of 100 mm are best.

Time frame: From baseline (Day 1) to end of treatment (Day 126)

Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS

Measured in mm. VAS appetite questions record the participant's sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.

Time frame: From baseline (Day 1) to end of treatment (Day 126)

• Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score

Measured in score points. The COEQ is a self-reported measure assessing various aspects of eating behaviour and related psychological factors. The COEQ has 19 different questions designed to assess the intensity and type of food cravings, as well as subjective sensations of appetite and mood. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control (0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); Higher score represents a greater level of Craving Control.

Time frame: From baseline (Day -1) to end of treatment (Day 125)

Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score

Measured in score points. The power of food questionnaire measures three factors that correspond to different levels of food proximity and reflect responsiveness to food-abundant environments: food available (food that is available, but not physically present), food present (food that is present, but not tasted), and food tasted (food that is tasted, but not consumed). Moreover, an aggregate score is calculated as the mean of the three subdomains. The questionnaire consists of 15 questions, and the participants will be asked to rate their agreement or disagreement with each statement on a 5-point scale (ranging from "strongly disagree" to "strongly agree").

Time frame: From baseline (Day -1) to end of treatment (Day 125)

A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts