Trial Outcomes & Findings for Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects (NCT NCT06621017)

Results Overview

The amount of food (weight and energy content) consumed during lunch after administration of ROSE-010 at 2 dose levels compared to placebo.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

30 minutes

Results posted on

2026-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Saline solution	ROSE-010 99 mcg ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg ROSE-010 solution, 150 mcg, 0.5 ml
Overall Study STARTED	10	15	15
Overall Study COMPLETED	10	15	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants by age group

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=24 Participants • Participants by age group	0 Participants n=24 Participants • Participants by age group	0 Participants n=48 Participants • Participants by age group	0 Participants n=100 Participants • Participants by age group
Age, Categorical Between 18 and 65 years	10 Participants n=24 Participants • Participants by age group	15 Participants n=24 Participants • Participants by age group	15 Participants n=48 Participants • Participants by age group	40 Participants n=100 Participants • Participants by age group
Age, Categorical >=65 years	0 Participants n=24 Participants • Participants by age group	0 Participants n=24 Participants • Participants by age group	0 Participants n=48 Participants • Participants by age group	0 Participants n=100 Participants • Participants by age group
Sex/Gender, Customized Female	10 Participants n=24 Participants	15 Participants n=24 Participants	15 Participants n=48 Participants	40 Participants n=100 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants	0 Participants n=24 Participants	1 Participants n=48 Participants	1 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	5 Participants n=24 Participants	7 Participants n=24 Participants	6 Participants n=48 Participants	18 Participants n=100 Participants
Race (NIH/OMB) White	5 Participants n=24 Participants	7 Participants n=24 Participants	6 Participants n=48 Participants	18 Participants n=100 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	1 Participants n=24 Participants	2 Participants n=48 Participants	3 Participants n=100 Participants

PRIMARY outcome

Timeframe: 30 minutes

The amount of food (weight and energy content) consumed during lunch after administration of ROSE-010 at 2 dose levels compared to placebo.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Food Consumption	605.5 weight food eaten g Standard Error 0	404.3 weight food eaten g Standard Error 80.55	423.6 weight food eaten g Standard Error 79.43

SECONDARY outcome

Timeframe: 6.5 hours Day 7

Hunger across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is not hungry at all and 100 is maximum hunger. AUE is a sum of hunger across the time period and is calculated as h\*mm. Simplistically, if the subject was not hungry at all across the period the AUE would be zero. The higher the AUE number, the higher the level of hunger throughout the observation period.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Hunger	220.5 AUE defined as h*mm Interval 0.0 to 424.3	212.5 AUE defined as h*mm Interval 3.5 to 359.8	177.1 AUE defined as h*mm Interval 15.2 to 405.4

SECONDARY outcome

Timeframe: 6.5 hours Day 7

Satiety across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is not feeling full at at all and 100 is maximum feeling of fullness. AUE is a sum of satiety across the time period and is calculated as h\*mm. Simplistically, if the subject was not full at all across the period the AUE would be zero. The higher the AUE number, the higher the level of satiety throughout the observation period.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Satiety	340.3 AUE defined as h*mm Interval 105.9 to 656.0	328.1 AUE defined as h*mm Interval 0.0 to 656.0	286.6 AUE defined as h*mm Interval 0.0 to 536.1

SECONDARY outcome

Timeframe: 6.5 hours Day 7

Prospective consumption across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is indicates no anticipated need to eat and 100 is maximum anticipated need to eat. AUE is a sum of prospective consumption across the time period and is calculated as h\*mm. Simplistically, if the subject has no anticipated need or desire to eat at all across the period the AUE would be zero. The higher the AUE number, the higher the level of prospective consumption throughout the observation period.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Prospective Consumption	247.6 AUE defined as h*mm Interval 2.5 to 571.6	227.2 AUE defined as h*mm Interval 7.6 to 362.6	183.6 AUE defined as h*mm Interval 12.7 to 372.4

SECONDARY outcome

Timeframe: 6.5 hours Day 7

Desire to eat across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is no desire to eat at all and 100 is maximum desire to eat. AUE is a sum of the desire to eat across the time period and is calculated as h\*mm. Simplistically, if the subject had no desire to eat at all across the period the AUE would be zero. The higher the AUE number, the higher the desire to eat throughout the observation period.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Desire to Eat	223.6 AUE defined as h*mm Interval 0.0 to 508.7	219.8 AUE defined as h*mm Interval 4.1 to 357.7	166.0 AUE defined as h*mm Interval 3.8 to 372.0

SECONDARY outcome

Timeframe: 30 minutes Day 7

Palatability (tastiness) score on a visual analogue scale (0 to 100 mm) where 0 is not palatable at all and 100 is the maximum palatibility. The higher the score, the more palatable the reported outcome.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Palatability	74.4 Scores on VAS scale Interval 16.0 to 100.0	55.9 Scores on VAS scale Interval 0.0 to 92.0	58.4 Scores on VAS scale Interval 5.0 to 88.0

SECONDARY outcome

Timeframe: 6.5 hours Day 7

Nausea across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is not nauseous at all and 100 is maximum nausea. AUE is a sum of hunger across the time period and is calculated as h\*mm. Simplistically, if the subject was not nauseous at all across the period, the AUE would be zero. The higher the AUE number, the higher the level of nausea throughout the observation period.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Nausea	0.0 AUE defined as h*mm Interval 0.0 to 0.0	0.17 AUE defined as h*mm Interval 0.0 to 2.4	3.38 AUE defined as h*mm Interval 0.0 to 41.07

SECONDARY outcome

Timeframe: Day 7

Population: The placebo group was not analyzed for ROSE-010 PK.

Plasma PK analysis of ROSE-010: Time to max plasma concentration in minutes

Outcome measures

Outcome measures
Measure	Placebo Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Plasma PK Analysis of ROSE-010 Time to Max Concentration Tmax	—	26 Minutes Interval 20.0 to 45.0	26 Minutes Interval 20.0 to 45.0

SECONDARY outcome

Timeframe: Day 7

Population: The placebo group were not analyzed for PK

Plasma PK analysis of ROSE-010, measurement of max plasma concentration.

Outcome measures

Outcome measures
Measure	Placebo Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Plasma PK Analysis of ROSE-010 Cmax	—	0.907 ng/mL Standard Deviation 0.257	1.06 ng/mL Standard Deviation 0.440

SECONDARY outcome

Timeframe: Day 7

Time of plasma elimination half-life calculated for both ROSE-010 doses

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Saline solution	ROSE-010 99 mcg n=15 Participants ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 Participants ROSE-010 solution, 150 mcg, 0.5 ml
Half-life	0 Minutes Standard Deviation 0	34.7 Minutes Standard Deviation 11.4	39.8 Minutes Standard Deviation 13.4

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ROSE-010 99 mcg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

ROSE-010 150 mcg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=10 participants at risk Saline solution	ROSE-010 99 mcg n=15 participants at risk ROSE-010 solution, 99 mcg, 0.5 ml	ROSE-010 150 mcg n=15 participants at risk ROSE-010 solution, 150 mcg, 0.5 ml
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 2 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study	60.0% 9/15 • Number of events 18 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study	46.7% 7/15 • Number of events 26 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study
Nervous system disorders Nervous system disorders	0.00% 0/10 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study	33.3% 5/15 • Number of events 8 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study	26.7% 4/15 • Number of events 8 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study
General disorders general disorders and administration site conditions	10.0% 1/10 • Number of events 1 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study	13.3% 2/15 • Number of events 2 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study	0.00% 0/15 • From baseline to the end of follow up, 15 days total. Subjects were discharged from the clinic 24 hours after the final treatment (Day 8) and followed up by telephone for safety assessment after a further 7 days. Adverse events were collected by clinicians conducting the study

Additional Information

Enda Kenny PhD

Rose Pharma Inc

Phone: +353 87 997 0841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place