Oral Presentation ANZOS Annual Scientific Meeting 2021

Once-weekly subcutaneous semaglutide 2.4mg reduces body weight in adults with overweight or obesity regardless of baseline characteristics (STEP 1) (#73)

Samantha L Hocking 1 2 , Robert F Kushner 3 , W Timothy Garvey 4 , Dan Hesse 5 , Anna Koroleva 5 , Soo Lim 6 , Ildiko Lingvay 7 , Ofri Mosenzon 8 , Signe OR Wallenstein 5 , Thomas A Wadden 9 , Carel W le Roux 10
  1. Charles Perkins Centre, Faculty of Medicine and Health, The University of Sydney Central Clinical School, Sydney, NSW, Australia
  2. Department of Endocrinology, Royal Prince Alfred Hospital Sydney , Sydney, NSW, Australia
  3. Division of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
  4. Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA
  5. Novo Nordisk A/S, Søborg, Denmark
  6. Department of Internal Medicine, Seoul National University College of Medicine, Seongnam, Republic of Korea
  7. UT Southwestern Medical Center, Dallas, TX, USA
  8. Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Ein Kerem, Israel
  9. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
  10. Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland

Aims: Semaglutide is a long-acting, subcutaneous, GLP-1 analogue currently being investigated for obesity management in adults with overweight or obesity in the STEP clinical trial programme. This post-hoc analysis of STEP-1 investigated weight loss in subgroups of participants based on baseline characteristics.

Methods: A randomised, double-blind, placebo-controlled, phase 3 trial (NCT03548935). Adults aged ≥18 years with either BMI ≥27kg/m2 with ≥1 weight-related comorbidity or BMI ≥30kg/m2, without type 2 diabetes, were randomised 2:1 to 68 weeks’ treatment with once-weekly subcutaneous semaglutide 2.4mg or placebo, as adjunct to lifestyle intervention. A descriptive evaluation of categorical weight loss with semaglutide from baseline to week 68 (≥20%, 15-<20%, 10-<15%, 5-<10%) by baseline characteristics (age, sex, race, body weight, BMI, waist circumference and glycaemic status) was conducted. Mean percent weight loss with semaglutide from baseline to week 68 was analysed separately by sex and baseline body weight using MMRM analysis with treatment, subgroup and the interaction between treatment and subgroup as factors, and baseline body weight as a covariate; all nested within visit.

Results: STEP 1 included 1,961 randomised participants (mean age 46 years, body weight 105.3kg, BMI 37.9kg/m2; 74.1% female). For categorical weight loss, observed proportions of participants with ≥20%, 15-<20%, 10-<15% and 5-<10% weight loss at week 68 were 34.8%, 19.9%, 20.0% and 17.5% with semaglutide vs 2.0%, 3.0%, 6.8% and 21.2% with placebo, respectively. Distribution of participants across weight loss groups did not appear to be affected by any baseline characteristics, except sex and baseline body weight. Mean percent weight loss at week 68 with semaglutide was greater among females than males, and in participants with lower vs higher baseline body weight.

Conclusions: Weight loss with semaglutide was seen in all subgroups evaluated. Female sex and low baseline body weight were associated with greater response to semaglutide.