Novo’s Experimental Weight-Loss Drug Delivers 25% Average Loss in Women, Analysis Finds

CagriSema’s New Women’s Data Put Menopause in the Weight-Loss Spotlight

The Next Weight-Loss Injection

Women Lost a Quarter of Their Weight in Novo Drug Analysis

Women receiving Novo Nordisk’s experimental obesity treatment CagriSema lost an average of 25 per cent of their starting weight after 68 weeks, the company said on 20 October.

The finding comes from a post hoc analysis of REDEFINE 1, an existing late-stage clinical trial. That means researchers examined the data after the study, rather than conducting a new trial designed specifically to test this women’s health question.

It is a substantial result. It also needs to be read alongside the original trial, its safety findings and the limits of subgroup research.

What the Women’s Analysis Found

The analysis covered 2,309 female participants. Novo reported average weight loss of 25 per cent with CagriSema, compared with 3 per cent with placebo.

A separate analysis examined outcomes by menopause stage. Average reductions were 26.7 per cent before menopause, 24.8 per cent during the transition and 23.1 per cent after menopause.

These are group averages, rather than a prediction of what any individual woman would lose. A quarter of starting body weight would represent 25 kilograms for someone weighing 100 kilograms. That example illustrates the scale of the percentage; it is not a description of the participants’ actual starting weights.

Novo described the analyses as hypothesis-generating and requiring further study.

The company’s scientific programme lists the two posters for presentation on 22 October at The Menopause Society meeting in San Diego. At the time checked, their accompanying materials were marked as coming soon.

How CagriSema Works

CagriSema combines two medicines in a weekly injection: semaglutide and cagrilintide.

Semaglutide is the active ingredient in Wegovy. It acts on the receptor for glucagon-like peptide-1, usually shortened to GLP-1. Cagrilintide is an analogue of amylin, another hormone involved in regulating appetite.

The combination targets complementary biological pathways. Its development asks whether adding amylin activity can produce greater weight reduction than either component alone.

The studied higher-dose combination contains 2.4 milligrams of each medicine. Calling it simply a 2.4-milligram injection can obscure that it contains two active components.

The treatment remains investigational. The new women’s analysis is evidence about a medicine under development, rather than a newly available prescription option.

Why the Original Trial Still Matters

REDEFINE 1 enrolled 3,417 adults without diabetes. Participants had obesity, or overweight with at least one obesity-related complication.

The trial compared the combination with semaglutide alone, cagrilintide alone and placebo. Treatment was accompanied by lifestyle intervention.

Its published overall result showed average weight reduction of 20.4 per cent with CagriSema, compared with 3 per cent with placebo, when researchers evaluated outcomes regardless of whether participants remained on treatment.

Another estimate, based on a scenario in which everyone stayed on their assigned treatment without other weight-loss therapies, produced a larger reduction of 22.7 per cent.

Those figures answer different questions.

One estimates the effect of assigning treatment while allowing for interruptions and other events during the trial. The other estimates its effect under continued treatment. Neither should be presented without explaining the assumption behind it.

The new women’s result also concerns a subgroup. It should not replace the overall trial figure or be treated as the expected outcome for every person prescribed the medicine in future.

What Menopause Comparisons Can Establish

Looking at reproductive stages can help identify questions that a combined trial average leaves unanswered.

However, women were not randomly assigned to be premenopausal, perimenopausal or postmenopausal. Those groups may differ in age, starting characteristics and other factors relevant to treatment response.

The numerical differences therefore do not establish that menopause itself caused a weaker or stronger response. Nor does a result within each group automatically establish a statistically reliable difference between the groups.

That would require examining the full methods, group sizes, uncertainty around the estimates and any formal tests comparing treatment effects.

Researchers would also need to consider how menopause status was classified and how hormone therapy use was handled. The title of Novo’s menopause-specific poster indicates that hormone therapy was part of the investigation, but the publicly available schedule does not provide the underlying results.

These details matter before turning an exploratory finding into advice about which women should receive a treatment.

Side Effects Belong Beside the Weight-Loss Figure

The broader trial provides an important counterweight to the headline percentage.

Novo’s published REDEFINE 1 safety summary reported gastrointestinal adverse events in 79.6 per cent of participants receiving CagriSema, compared with 39.9 per cent receiving placebo. Nausea, constipation and vomiting were among the reported effects.

Treatment discontinuation because of adverse events occurred in 5.9 per cent of the combination group and 3.5 per cent of the placebo group.

Those are findings from the overall trial, rather than the new menopause subgroups.

For an individual patient, a medicine’s value depends partly on whether its benefits can be sustained at a tolerable dose. Average weight reduction alone cannot settle that decision.

It also cannot establish every longer-term health outcome. Weight loss and protection against cardiovascular events are separate endpoints, even when they may be related. The distinction also matters when interpreting comparisons of Ozempic and Mounjaro on cardiovascular risk.

What Happens Next

Novo submitted its US application for CagriSema in December 2025. Regulatory assessment must consider the complete evidence on efficacy, safety and the proposed use of the combination.

The women’s analyses add a more specific research question to that wider assessment. Future work can test whether the apparent differences across reproductive stages hold up under a study designed to investigate them.

For now, the immediate opportunity to scrutinise the findings is the release of the full conference materials. Those should show how the headline estimates were calculated, how uncertainty was measured and what the subgroup comparisons can support.

Sources

Next Reads

Next
Next

Merck’s $1.3 Billion Gene-Silencing Deal: The Medicines That Could Change Patients’ Lives