Short-term effect of beinaglutide combined with metformin versus metformin alone on weight loss and metabolic profiles in obese patients with polycystic ovary syndrome: a pilot randomized trial

Qing Wen; Song Fang; Yanjing Liang; Yuting Tian; Yiding Chen; Jun Yuan; Qiu Chen

doi:10.3389/fendo.2023.1156521

Short-term effect of beinaglutide combined with metformin versus metformin alone on weight loss and metabolic profiles in obese patients with polycystic ovary syndrome: a pilot randomized trial

Front Endocrinol (Lausanne). 2023 Jun 6:14:1156521. doi: 10.3389/fendo.2023.1156521. eCollection 2023.

Authors

Qing Wen¹, Song Fang², Yanjing Liang¹, Yuting Tian¹, Yiding Chen¹, Jun Yuan¹, Qiu Chen¹

Affiliations

¹ Medical Department of Endocrinology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
² Medical Department of Endocrinology, The Traditional Chinese Medicine Hospital of Longquanyi, Chengdu, China.

Abstract

Objective: To observe the effect of beinaglutide combined with metformin versus metformin alone on weight loss and metabolic profiles in obese patients with polycystic ovary syndrome(PCOS).

Methods: A total of 64 overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomly assigned to metformin(MET) 850 mg twice a day(BID) or combined MET 850 mg BID with beinaglutide (COMB) starting at 0.1mg three times a day(TID)and increasing to 0.2mg TID two weeks later. The main endpoints were changes in anthropometric measurements of obesity. Glucose and lipid metabolic, gonadal profiles, and antral follicle count changes as secondary outcomes were also observed.

Results: 60(93.75%) patients completed the study. In terms of lowering weight, body mass index (BMI),waist circumference(WC) and waist to height ratio(WHtR), COMB treatment outperformed MET monotherapy. Subjects in the COMB arm lost weight 4.54±3.16kg compared with a 2.47±3.59kg loss in the MET arm. In the COMB group, BMI,WC and WHtR were reduced significantly compared with that in the MET group, respectively. COMB therapy is also more favorable in the reduction of fasting insulin(FINS), total testosterone(TT), and homeostasis model assessment-insulin resistance(HOMA-IR) when compared to MET therapy. Antral follicle count and ovarian volume were non-significantly changed in both groups.The most frequent side effects in both groups were mild and moderate digestive symptoms. Itching and induration at the injection site were reported with COMB treatment.

Conclusion: Short-term combined treatment with beinaglutide and metformin appears superior to metformin monotherapy in lowering body weight, BMI, WC,WHtR and improving insulin sensitivity and androgen excess in women with PCOS and obesity, with tolerable adverse events.

Clinical trial registration: https://www.chictr.org.cn/listbycreater.aspx, identifier ChiCTR2000033741.

Keywords: beinaglutide; gonadal profiles; metformin; obesity; polycystic ovary syndrome; weight loss.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Female
Humans
Insulin Resistance*
Metformin*
Obesity / chemically induced
Obesity / complications
Obesity / drug therapy
Pilot Projects
Polycystic Ovary Syndrome* / complications
Polycystic Ovary Syndrome* / diagnosis
Polycystic Ovary Syndrome* / drug therapy
Weight Loss

Substances

Metformin
glucagon-like peptide 1 (7-36)

Grants and funding

This RCT is funded by the horizontal projects of Shanghai Benemae Pharmaceutical Corporation (Project Number: 2017-F-13). The funder had no role in the development and preparation of the manuscript.