A randomised, placebo-controlled, double-blinded, cross-over, Phase 1 study evaluating the safety and preliminary efficacy of the GLP 1 analogue ROSE-010 on appetite and food intake in overweight and obese subjects.

Start 10 Nov 2023 · End 16 Jan 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol RP-23-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 12

Countries 1

Sites 1

Overweight

Key facts

Sponsor: Rose Pharma Inc.
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration: 10 Nov 2023 → 16 Jan 2024
Decision date (initial): 2023-11-09
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Overweight

Version	Level	Code	Term	System organ class
20.0	PT	10033307	Overweight	100000004861
20.0	PT	10029883	Obesity	100000004861

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rose Pharma Inc.

Sponsor organisation: Rose Pharma Inc.
Address: 3500 Pacific Avenue
City: Virginia Beach
Postcode: 23451-2818
Country: United States

Scientific contact point

Organisation: Rose Pharma Inc.
Contact name: CTC Clinical Trial Consultants AB, att. Anders Millerhovf

Public contact point

Organisation: Rose Pharma Inc.
Contact name: CTC Clinical Trial Consultants AB, att. Anders Millerhovf

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ended	12	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Ended

CTC Clinical Trial Consultants AB

CTC, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Sweden	2023-11-10	2024-01-16	2023-11-10	2024-01-03

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-09-01	Sweden	Acceptable 2023-11-09	2023-11-09