EP639 - ECE_3171 - Efficacy and safety of semaglutide injection in weight management: a subgroup analysis in mild renal impairment patients
Year: 2026
Type: conference-abstract
Abstract: Objectives To evaluate the efficacy and safety of synthetic semaglutide injection (Test drug) compared with Wegovy® (Reference drug) dosage up to 2.4 mg subcutaneously for weight management in mild renal impairment patients (eGFR 60 to <90 mL/min/1.73 m²). Materials and Methods A phase III, multicentre, randomized, open-label, active-controlled clinical study (CTRI/2025/04/085487) was conducted across 22 study sites in India after receiving regulatory and ethics committee approvals. In this study, 267 adult patients with (BMI) ≥ 30 kg/m2 or ≥27 kg/m2 with the presence of at least one co-morbidity of hypertension, dyslipidaemia and/or type 2 diabetes mellitus were included. Patients were randomized to receive either test drug or reference drug weekly subcutaneously for 24 weeks. Results Total 101 patients with eGFR 60 to <90 mL/min/1.73 m² at baseline were included in this study. In this group mean (±SD) percentage reduction in weight from baseline to week 24 was −14.2 (± 3.17) with test drug and −13.7 (± 2.82) with reference drug. The decrees in weight with the test and the reference drug was comparable (P = .6248). The proportion of patients achieving ≥ 5% weight loss was 98.6% with test drug and 100% with reference drug (P = .5403) at week 24. The proportion of patients achieving ≥10% weight loss was 88.7% with test drug and 86.7% with reference drug (P = .6028) at week 24 At Week 24, Mean (± SD) change from baseline in BMI with test and the reference drug was − 4.76 (± 1.14) kg/m2 and −4.67 (± 1.12) kg/m2 respectively (P = .5494). Mean (± SD) change in waist circumference with test and the reference drug was −10.2 (± 4.59) cm and −9.57 (± 3.50) cm respectively (P = .5098) at week 24. The change in BMI and waist circumference was comparable between the test and the reference drug at week 24 In diabetic patients there was decrease in glycaemic parameters (HbA1c, FBG and PPBG) from baseline to week 24 in both S1 and S2 and was comparable between arms (P > .05). In non-diabetic patients decrease in glycaemic parameters (HbA1c, FBG and PPBG) from baseline to week 24 was not clinically relevant compared to diabetic patients and was comparable between arms (P > .05). Study medications were well tolerated. Conclusions Semaglutide injection is effective in reducing weight in mild renal impairment patients and can be a treatment of choice in management of weight in patients with mild renal impairment.
Authors: Unnikrishnan Gopalkrishnan, Ameya Joshi, Harish Kumar, Richa Giri, Sanjiv Maheshswari, Valluri Prasad, Jitendra Shukla, M C Rekha, Nutankumar Agrawal, Yogesh Rasal, Banshidhar Sahoo, Shweta Bhandari, Ambana Gowda, Phadke Keshav, Pravin Supe, Niranjan Pathak, C Ambrish, Ashutosh Sonawane, Yash Bahulikar, Amit Bhaskar, R Arunkumar, Priyanka Yadav, Supriya Sonowal, Dipak Patil, Sucheta Pandit, Pravin Ghadge, Suyog Mehta
Institutions: Chellaram Hospital, Bhaktivedanta Hospital & Research Institute, Amrita Institute of Medical Sciences and Research Centre, Ganesh Shankar Vidyarthi Memorial Medical College, Jawaharlal Nehru Medical College, King George Hospital, Mandya Institute of Medical Sciences, Maharani Laxmi Bai Medical College, Sahyadri Hospital, Joshi Hospital, Chettinad Health City, Sun Pharma (India)
Language: English
Subfield: Pharmacology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,292
OpenAlex ID: W7213344851