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Novo's CagriSema shows 21% weight loss at lower doses in phase 3 trial

Novo's CagriSema shows 21% weight loss at lower doses in phase 3 trial

New Capabilities

REDEFINE 9 results, presented at ObesityWeek 2026 and published in The Lancet Diabetes & Endocrinology, point to dosing flexibility ahead of an FDA decision on the highest dose.

Today: REDEFINE 9 results presented and published

Overview

Updated 1 hour ago

A lower dose of Novo Nordisk's experimental obesity drug CagriSema produced about 21% average weight loss over 68 weeks, the company reported. That is close to the 22.7% the program's highest dose produced in an earlier trial, though the two studies used different designs and are not directly comparable.

The finding matters because it suggests patients who cannot tolerate the top dose may still get most of the benefit. Novo has already asked the U.S. Food and Drug Administration to approve the 2.4 mg/2.4 mg version, with a decision expected in the fourth quarter of 2026.

Why it matters

If lower doses work nearly as well, more patients can stay on treatment, widening the market Novo can reach with one drug.

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Key Indicators

21.0%
Weight loss at CagriSema 1.0 mg/1.0 mg
Average reduction at 68 weeks under the efficacy estimand, versus 2.0% for placebo.
20.7%
Weight loss at CagriSema 1.7 mg/1.7 mg
Average reduction at 68 weeks under the efficacy estimand.
2.0%
Weight loss on placebo
Pooled placebo arm at 68 weeks under the efficacy estimand.
309
Participants randomized
Adults with overweight or obesity and without diabetes.
2.9%
Discontinuation at 1.7 mg/1.7 mg
Adverse events leading to permanent treatment discontinuation, versus 4.9% on placebo.

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People Involved

SW
Sean Wharton
Lead author of the REDEFINE 9 paper; obesity physician
Presented the trial results at ObesityWeek 2026

Organizations Involved

Novo Nordisk
Novo Nordisk
Pharmaceutical company
Developer of CagriSema; awaiting FDA decision on the 2.4 mg/2.4 mg dose

Danish drugmaker that makes semaglutide-based obesity and diabetes medicines and is developing CagriSema.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Reviewing Novo's application for CagriSema 2.4 mg/2.4 mg

The agency that decides whether CagriSema can be sold in the United States.
Eli Lilly and Company
Eli Lilly and Company
Pharmaceutical company
Competitor in the obesity drug market with tirzepatide

Maker of tirzepatide, the main competing obesity drug against Novo's semaglutide and CagriSema.

Timeline

August 2025 November 2026

4 events Latest: Today
Tap a bar to jump to that date

  1. REDEFINE 9 results presented and published

    Today Clinical trial

    CagriSema 1.7 mg/1.7 mg and 1.0 mg/1.0 mg produced 20.7% and 21.0% average weight loss at 68 weeks, versus 2.0% for placebo, under the efficacy estimand.

  2. REIMAGINE 5 topline results announced

    Clinical trial

    Novo reported topline results from a head-to-head trial of CagriSema against tirzepatide 5 mg, alongside the REDEFINE 9 readout.

  3. Novo files for FDA approval

    Regulatory

    Novo submitted a New Drug Application for CagriSema 2.4 mg/2.4 mg for weight management, with a decision expected in the fourth quarter of 2026.

  4. REDEFINE 1 results published

    Clinical trial

    The 2.4 mg/2.4 mg dose showed 20.4% weight loss under the treatment-policy estimand in a 3,417-patient trial, or 22.7% under the efficacy estimand.

Scenarios

1

FDA approves CagriSema 2.4 mg/2.4 mg for weight management

Likely Resolves by End of 2026

Discussed by: Novo Nordisk, which has said it expects a decision in the fourth quarter of 2026

The application filed in December 2025 clears review, and CagriSema becomes a marketed obesity drug in the United States. Approval would put a third mechanism, the amylin analog cagrilintide, into the commercial obesity market alongside GLP-1 and GIP/GLP-1 drugs.

2

FDA issues a complete response letter and delays CagriSema

Possible Resolves by Q2 2027

Discussed by: Implied by the gap between Novo's stated Q4 2026 timeline and the absence of an approval as of the REDEFINE 9 readout

The agency declines to approve the application in its current form, asking for more data or a manufacturing fix. Novo would need to respond, pushing any U.S. launch into 2027 or later and giving competitors more time to hold market share.

3

Novo files separately for lower-dose CagriSema

Possible Resolves by End of 2027

Discussed by: REDEFINE 9 investigators, who describe the lower doses as offering dosing flexibility

Novo uses the REDEFINE 9 data to seek approval of 1.7 mg/1.7 mg or 1.0 mg/1.0 mg as additional options, letting doctors start patients lower or step them down. That would require a new filing and a second review cycle.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1997

Fen-phen withdrawal (1997)

A combination of fenfluramine and phentermine, widely prescribed for weight loss, was linked to heart valve damage. The FDA asked manufacturers to withdraw fenfluramine from the market.

Then

The drugs came off the market and patients were told to stop taking them.

Now

The episode left regulators and the public wary of combination obesity drugs for years, slowing investment in the field.

Why this matters now

CagriSema is also a fixed-dose combination. Its safety data, including discontinuation rates, carry more weight because of that history.

June 2021

Semaglutide approved for weight management (2021)

The FDA approved semaglutide 2.4 mg, sold as Wegovy, for chronic weight management, the first new obesity drug approved in years.

Then

Demand outstripped supply, and the drug became a cultural phenomenon.

Now

It established a commercial obesity market and set the benchmark every later drug is measured against.

Why this matters now

CagriSema pairs semaglutide with a second hormone. REDEFINE 9 tests whether that combination can beat semaglutide alone at lower doses.

November 2023

Tirzepatide approved for obesity (2023)

Eli Lilly's tirzepatide, sold as Zepbound, won FDA approval for chronic weight management, giving the market a second major competitor.

Then

Lilly and Novo split the obesity market and competed on supply and pricing.

Now

Head-to-head trials between the two companies' drugs became the standard way to differentiate them.

Why this matters now

Novo has run CagriSema against tirzepatide 5 mg in REIMAGINE 5, and the REDEFINE 9 dosing data shape how that comparison is read.

Sources

(5)
PR Newswire / Novo Nordisk ObesityWeek 2026 Small Molecule News MarketScreener Novo Nordisk U.S.