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Menopause

Oral GLP-1 shows significant weight loss in all menopause stages – study

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The highest dose of an oral GLP-1 was linked to significant weight loss across menopause stages in post-hoc analyses of two late-stage trials.

The results suggest Foundayo may help women with obesity or overweight lose weight during premenopause, perimenopause and post-menopause.

Women taking the highest dose also saw reductions in waist circumference, a measure linked to abdominal fat and cardiometabolic risk.

The analyses were based on more than 1,500 female participants in the ATTAIN-1 and ATTAIN-2 clinical trials.

GLP-1 medicines mimic a hormone that helps regulate appetite and blood sugar. They are used in weight management and diabetes care.

Cardiometabolic risk means the likelihood of developing conditions such as heart disease, high blood pressure or type 2 diabetes.

The findings were presented at the American Diabetes Association’s 86th Scientific Sessions.

Eli Lilly and Company said women taking the highest dose of Foundayo, the brand name for orforglipron, achieved significant weight loss at every stage of menopause.

Orforglipron is a once-daily oral GLP-1 receptor agonist. Unlike injectable GLP-1 medicines, it is taken as a tablet.

Menopause is the point at which menstrual periods have permanently stopped. Perimenopause is the transition before menopause, when hormone levels and periods can change.

The company said menopause can contribute to weight gain, particularly around the abdomen, and may make weight loss harder to achieve and maintain.

Rachel Batterham, senior vice-president of medical innovation and external engagement at Lilly, said: “Menopause can be an incredibly frustrating time for many women, partly because weight gain often feels beyond their control, and the biology of menopause can undermine even the most determined efforts to manage weight.

“These findings show that Foundayo was associated with meaningful weight loss in women at every stage of menopause.

“For women who have seen their weight become harder to manage precisely when their health is more at risk, this is what progress could look like.”

In ATTAIN-1, women without diabetes who were premenopausal lost up to 12.8 per cent of their body weight after 72 weeks on the highest dose.

Women in perimenopause lost up to 14.4 per cent, while post-menopausal women lost up to 14.1 per cent.

This was equivalent to 28.0 lbs, 30.4 lbs and 28.2 lbs respectively.

At the highest dose, up to 51.5 per cent of women in ATTAIN-1 achieved at least 15 per cent weight loss.

Waist circumference fell by up to 4.9 inches in the trial.

In ATTAIN-2, which involved adults with obesity or overweight and type 2 diabetes, women also lost weight across menopause stages.

Premenopausal women lost up to 11.3 per cent of their body weight, perimenopausal women lost up to 8.9 per cent and post-menopausal women lost up to 13.6 per cent.

This was equivalent to 23.4 lbs, 18.5 lbs and 27.8 lbs respectively.

At the highest dose, up to 44.2 per cent of women in ATTAIN-2 achieved at least 15 per cent weight loss.

Waist circumference reductions reached up to 4.3 inches.

ATTAIN-1 was a 72-week phase 3 trial comparing three doses of Foundayo with placebo in adults with obesity, or overweight with at least one weight-related condition, who did not have diabetes.

ATTAIN-2 was a 72-week phase 3 trial in adults with obesity or overweight and type 2 diabetes.

A placebo is an inactive treatment used for comparison in a clinical trial.

Both trials tested the drug alongside lifestyle measures, including diet and physical activity.

The analyses were post-hoc, meaning they looked at the data after the trial results had already been collected.

Post-hoc analyses can help identify patterns, but they are generally considered less definitive than findings from trials designed specifically to answer that question.

Foundayo is approved by the FDA in the US for adults with obesity, or some adults with overweight and weight-related medical problems, to reduce excess body weight and maintain weight reduction alongside diet and physical activity.

The source material states that the drug should not be used with other GLP-1 receptor agonist medicines and that it is not known whether it is safe and effective in children.

It also states that oral birth control pills may not work as well while taking Foundayo, and that healthcare professionals may recommend another form of contraception for 30 days after starting the drug and for 30 days after each dose increase.

Common side effects listed in the source material include nausea, constipation, diarrhoea, vomiting, indigestion, abdominal pain, headache, swollen belly, tiredness, belching, heartburn, gas and hair loss.

The company said orforglipron is also being studied for type 2 diabetes, obstructive sleep apnoea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.

Menopause

Many women still confused about perimenopause, research finds

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One in three US women older than 35 are no sure whether they are in perimenopause, new research has revealed.

The findings suggest uncertainty remains common, largely because of knowledge gaps, symptom confusion and difficulty getting confirmation or care.

Perimenopause is the transitional stage before a woman’s final period, when hormone levels fluctuate and symptoms can change over time.

It usually begins in the mid-40s, although timing varies widely, and can last for around four to eight years.

Symptoms can include hot flushes, psychological symptoms and urogenital symptoms, which affect the urinary and genital areas.

Dr Stephanie Faubion, medical director for The Menopause Society and one of the study authors, said: “This large study showed that one in three US women aged older than 35 years are not sure whether they are in perimenopause.

“Further, the study highlights that symptom confusion, misconceptions, and barriers to care are leaving many women without the clarity and support they need during the menopause transition.

“Recognising perimenopause uncertainty as a common experience can help shift the conversation from searching for a diagnosis to providing women with the information, validation, and support they need to navigate this natural life transition with confidence.”

More than 7,600 US women aged 35 and older took part in the study, which looked at how common uncertainty around perimenopause is and what may be driving it.

Overall, 34 per cent of participants said they were unsure of their reproductive stage.

Uncertainty varied by age and symptom burden, reaching 42 per cent among women aged 40 to 44 and 37 per cent among those with severe symptoms.

Symptom confusion was the most common factor, cited in 56 per cent of responses.

This included difficulty making sense of bodily changes and telling perimenopause apart from other possible causes, such as premenstrual syndrome, thyroid disease or mental health conditions.

Knowledge gaps and information-seeking made up 28 per cent of responses, reflecting limited awareness, age-based assumptions and attempts to find reliable information.

Barriers to confirmation and care made up 16 per cent, including dismissive healthcare encounters and reluctance to acknowledge perimenopause.

Younger women aged 35 to 39 were more likely to cite knowledge gaps, while healthcare barriers were most common among women aged 40 to 44.

The researchers said clinicians should take a more flexible approach to recognising the emotional, cognitive and physical symptoms that can occur during perimenopause.

They said healthcare professionals should not rely too heavily on irregular periods as the main sign, because some women have symptoms before major cycle changes.

 

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New menopause drug approved for use by NHS in Scotland

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A new menopause drug has been approved for NHS use in Scotland, offering a non-hormonal option for women who cannot take HRT.

The Scottish Medicines Consortium has recommended that women can now be prescribed fezolinetant, also known as Veoza, for symptoms such as hot flushes and night sweats.

Some women cannot take HRT, leaving them with limited treatment options for symptoms that can be severe and long-lasting.

Dr Timir Patel, medical director of Astellas UK, said the company was “pleased that this important additional treatment option will be available to women in Scotland, helping to support more personalised care for those experiencing hot flushes and night sweats”.

Fezolinetant works by selectively blocking a neurotransmitter in the brain involved in triggering hot flushes.

Clinical trials have shown the drug can reduce both the frequency and severity of hot flushes and night sweats.

About 400,000 women in Scotland are said to be of menopausal age, with manufacturer Astellas Pharma Ltd saying up to 48,000 could benefit from the treatment.

Dr Rob Peel, chair of the Scottish Medicines Consortium, said: “We know that menopausal hot flushes and night sweats can substantially affect quality of life.

“For those who cannot take HRT, effective treatment options are limited. Fezolinetant provides a non-hormonal treatment option, and we know our decision will be welcomed.”

Dr Kay McAllister, consultant gynaecologist and clinical lead for menopause services at NHS Glasgow and Greater Clyde, said: “Today’s decision marks a positive development for the wellbeing of Scottish women.

“In clinical practice, I see how hot flushes and night sweats impact sleep and overall quality of life in my patients.

“The availability of this targeted treatment offers a welcome choice and further options for patients.”

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Avni Wellness secures US$470k funding

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Avni Wellness has secured Rs 4 crore, around US$470,000, in seed funding to expand its products and digital commerce capabilities.

The Mumbai-based women’s health start-up plans to strengthen its online retail operations and increase its presence across digital marketplaces.

It will also expand its cycle nutrition product range and grow its women-led network of micro-entrepreneurs.

Founded in 2021 by Sujata Pawar and Apurv Agarwal, Avni Wellness offers science-backed, toxin-free products spanning adolescence, reproductive years and menopause.

Its portfolio includes a patented antimicrobial reusable sanitary pad and a liposomal iron supplement designed to address iron deficiency among women in India.

Liposomal supplements encase nutrients in tiny fat-like particles intended to support absorption.

The company also offers products for polycystic ovary syndrome, or PCOS, calcium supplementation, urinary and vaginal health and seed-based hormonal nutrition. PCOS is a condition that can affect hormone levels, periods and fertility.

Proteus Partners led the funding round, with participation from angel investors Puru Gupta, Sreejith Moolayil, A. Velumani and Somya Nigam.

Avni Wellness said it aims to address gaps in women’s healthcare in India by focusing on hormonal health, nutrition and long-term wellbeing while incorporating livelihood generation and sustainability into its model.

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