Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000559415
Ethics application status
Approved
Date submitted
14/11/2024
Date registered
2/06/2025
Date last updated
2/06/2025
Date data sharing statement initially provided
2/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study Evaluating the Safety and Efficacy of Oral LMN-0801 Capsules for Weight Loss.
Scientific title
A Dose-ranging Study Evaluating the Safety and Efficacy of LMN-0801 for
Weight Loss in Overweight Adults
Secondary ID [1] 313349 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 335708 0
Condition category
Condition code
Diet and Nutrition 332273 332273 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three oral capsules (400 mg per capsule) containing LMN-0801 taken once per day (Group 1 and 2), twice per day (Group 4-6) and three times per day (Group 7-10) for 24 weeks.

Participants will be completing a daily questionnaire to record drug self-administration. Participants will also bring used and unused drug packaging with them to each clinic visit for drug accountability.
Intervention code [1] 329936 0
Treatment: Drugs
Comparator / control treatment
The placebo consists of a standard, vegetarian immediate-release capsule filled with starch.
Control group
Placebo

Outcomes
Primary outcome [1] 339869 0
Safety and tolerability of LMN-0801 assessed via incidence of moderate to severe adverse events. Composite outcome.
Timepoint [1] 339869 0
Patient-reported volunteered events weekly from baseline through Week 24 post-baseline, as well as AEs/SAEs recorded at clinic visits from baseline through week 29 post-baseline. Clinic visits will occur at Day 0 (Baseline), Day 7 (Week 1), Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 126 (Week 18), Day 168 (Week 24) and Day 203 (Week 28).
Secondary outcome [1] 447343 0
Proportion of subjects achieving >5% body weight reduction from baseline to week 24
Timepoint [1] 447343 0
Weight measurements in the clinic at baseline and on Day 7, Day 28, Day 56, Day 84, Day 126 and Day 168 (Week 24)
Secondary outcome [2] 447345 0
Occurrence of adverse events during Week 24 to Week 29
Timepoint [2] 447345 0
Week 24 to week 29
Secondary outcome [3] 447344 0
Change in percentage body fat from baseline to Week 24
Timepoint [3] 447344 0
In clinic at baseline, on Day 84 and on Day 168 (Week 24)
Secondary outcome [4] 441703 0
Change in body weight (kg and %) from baseline to Week 24
Timepoint [4] 441703 0
Weight measurements in the clinic at baseline and on Day 7, Day 28, Day 56, Day 84, Day 126 and Day 168 (Week 24)

Eligibility
Key inclusion criteria
• Adults aged 18 years and over and under age 65 years
• Body Mass Index (BMI) > 30 and < 40
• HbA1c < 6.5%
• In good general health
• Females agree to eliminate risk of pregnancy
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Significant illness, abnormal physical exam, lab findings (investigator discretion)
• Alcohol abuse or drug dependency or tobacco use
• Pregnant, breastfeeding, or planning to become pregnant or breastfeed
• Use of weight loss drugs and/or antidiabetic agents in preceding six months
• Currently treated with excluded medications
• Have previously completed or withdrawn from this study
• Participation in another clinical trial now or in the prior three months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317795 0
Commercial sector/Industry
Name [1] 317795 0
Lumen Bioscience, Inc.
Country [1] 317795 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Lumen Bioscience, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 320123 0
Commercial sector/Industry
Name [1] 320123 0
Lumen Bioscience Australia PtyLtd
Address [1] 320123 0
Country [1] 320123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316479 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316479 0
Ethics committee country [1] 316479 0
Australia
Date submitted for ethics approval [1] 316479 0
20/11/2024
Approval date [1] 316479 0
28/03/2025
Ethics approval number [1] 316479 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138022 0
Dr Anna Anderson
Address 138022 0
Barwon Health, Barwon Health, 272-322 Ryrie street, Geelong VIC 3220
Country 138022 0
Australia
Phone 138022 0
+61 3 42 15 2878
Fax 138022 0
Email 138022 0
[email protected]
Contact person for public queries
Name 138023 0
Carl Mason
Address 138023 0
Lumen Bioscience, Inc., 1441 N 34th St., Seattle, WA 98103
Country 138023 0
United States of America
Phone 138023 0
+1 2068991904
Fax 138023 0
Email 138023 0
[email protected]
Contact person for scientific queries
Name 138024 0
Carl Mason
Address 138024 0
Lumen Bioscience, Inc., 1441 N 34th St., Seattle, WA 98103
Country 138024 0
United States of America
Phone 138024 0
+1 2068991904
Fax 138024 0
Email 138024 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.