None listed
Conditions
Brief summary
This study is a Phase II randomised, double-blind, placebo-controlled, parallel-group trial evaluating the effects of SIR4156 in combination with semaglutide in adults with obesity. Participants will receive either SIR4156 or placebo tablets in addition to once-weekly semaglutide injections. The primary objective is to assess the effect of SIR4156 on body fat mass and body composition. Secondary objectives include evaluation of body weight, lean mass, safety, tolerability, pharmacokinetics, and pharmacodynamic effects. The study hypothesis is that SIR4156 in combination with semaglutide may reduce body fat mass and improve body composition in adults with obesity compared with placebo plus semaglutide.
Interventions
Participants in the intervention arm will receive SIR4156 oral tablets administered twice daily in combination with semaglutide administered as a once-weekly subcutaneous injection for 24 weeks. Participants will receive either 100 mg or 200 mg SIR4156 according to the protocol-defined randomised treatment assignment. Semaglutide dosing will be escalated according to the approved product schedule: 0.25 mg once weekly for Weeks 1–4, 0.5 mg once weekly for Weeks 5–8, 1.0 mg once weekly for Weeks 9
Participants in the intervention arm will receive SIR4156 oral tablets administered twice daily in combination with semaglutide administered as a once-weekly subcutaneous injection for 24 weeks. Participants will receive either 100 mg or 200 mg SIR4156 according to the protocol-defined randomised treatment assignment. Semaglutide dosing will be escalated according to the approved product schedule: 0.25 mg once weekly for Weeks 1–4, 0.5 mg once weekly for Weeks 5–8, 1.0 mg once weekly for Weeks 9–12, 1.7 mg once weekly for Weeks 13–16, and 2.4 mg once weekly from Week 17 onwards as the maintenance dose, as tolerated. Semaglutide injections will be self-administered by participants following training provided by the study team. Adherence to study treatment will be monitored throughout the study using participant dosing diaries, study drug accountability records, and reconciliation of returned study medication at each study visit. Participants will receive instructions on study treatment administration and diary completion, with compliance reviewed by site staff at scheduled visits.
Sponsors
Sironax Aus Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18 to 75 years with obesity defined as body mass index greater than or equal to 30 kilograms per square meter, with stable body weight prior to screening, and able to comply with study procedures.
Exclusion criteria
Participants with diabetes mellitus, use of weight loss medications within a recent period prior to screening, significant cardiovascular, hepatic or renal disease, pregnancy or breastfeeding, or any condition that in the opinion of the investigator would make participation unsafe or interfere with study results.
Outcome results
None listed