CagriSema for Obesity

Not currently recruiting at 44 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Disqualifiers: Diabetes

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine called CagriSema to evaluate its effectiveness in helping people with obesity lose weight and maintain the loss long-term. Participants will receive either CagriSema or a placebo (a substance with no active ingredients), assigned randomly. After the first phase, all participants will receive CagriSema to assess the effects of different doses. Suitable candidates for this trial are individuals with a BMI of 30 or higher who aim to lose at least 25% of their body weight. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that CagriSema is likely to be safe for humans?

Research has shown that CagriSema is generally well-tolerated in studies with people. One study found that CagriSema helped participants lose significant weight with few serious side effects. Notably, compared to similar treatments, CagriSema caused less vomiting, suggesting it might be gentler on the stomach for most people.

Another study demonstrated that CagriSema led to a greater reduction in blood pressure than semaglutide alone or a placebo, indicating potential additional health benefits beyond weight loss. Overall, the evidence suggests that CagriSema is safe for people, with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

CagriSema is unique because it combines two active ingredients, semaglutide and cagrilintide, which target both appetite and weight regulation simultaneously. Unlike standard obesity treatments that often focus solely on appetite suppression or metabolic enhancement, CagriSema works by mimicking natural hormones to control hunger and improve metabolic response. This dual-action approach could potentially lead to more effective and sustained weight loss compared to existing options. Researchers are excited about its potential to offer a more comprehensive solution for obesity management.

What evidence suggests that CagriSema might be an effective treatment for obesity?

Research has shown that CagriSema yields promising results for weight loss in people with obesity. One study found that participants taking CagriSema lost an average of 22.7% of their body weight over 68 weeks, while those on a placebo lost only 2.3%. Another study revealed that adults without diabetes lost up to 22.7% of their weight, and those with type 2 diabetes lost 15.7%. In this trial, participants will receive either CagriSema or a placebo. These findings suggest that CagriSema could be a strong option for significant weight loss in adults with obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 30 or higher who want to lose at least 25% of their body weight within about a year and a half. It's not for people with diabetes, as indicated by an HbA1c level of 6.5% or more.

Inclusion Criteria

I am 18 years old or older.

I am either male or female by birth.

BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening

Exclusion Criteria

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening

I have a history of diabetes (type 1 or 2).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Study Treatment

Participants receive CagriSema or placebo subcutaneously once weekly. CagriSema dose is escalated every 4 weeks for up to 16 weeks, followed by a maintenance dose for 64 weeks.

80 weeks

Extension Study

Participants continue on CagriSema with flexible dose escalation for 80 weeks.

80 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CagriSema

Trial Overview The study tests CagriSema, which combines two drugs (Cagrilintide B and Semaglutide I) against a placebo that looks the same but has no active ingredients. Participants have twice the chance to receive CagriSema over placebo and will take weekly injections for roughly three years.

How Is the Trial Designed?

Group I: CagriSema Experimental Treatment 1 Intervention

Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks.

Group II: Placebo Placebo Group 2 Interventions

Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. diabetes.org diabetes.org/newsroom/press-releases/cagrisema-demonstrates-significant-weight-loss-adults-obesity

CagriSema Demonstrates Significant Weight Loss in Adults ... Once-weekly medication results in weight loss of up to 22.7% in adults without diabetes and 15.7% in those with type 2 diabetes.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2502081

Coadministered Cagrilintide and Semaglutide in Adults ... In a phase 2 trial, cagrilintide at a dose of 2.4 mg led to a 9.7% weight reduction by week 26. ... We now provide the efficacy and safety results ...

3. pharmexec.com pharmexec.com/view/novo-nordisk-cagrisema-falls-short-25-weight-loss-target-patients-obesity-overweight

Novo Nordisk's CagriSema Falls Short of 25% Weight Loss ... Results from the Phase III REDEFINE 1 trial show that CagriSema led to a 22.7% mean weight reduction at 68 weeks in adults with overweight or obesity.

4. prnewswire.com prnewswire.com/news-releases/cagrisema-2-4-mg--2-4-mg-demonstrated-22-7-mean-weight-reduction-in-adults-with-overweight-or-obesity-in-redefine-1--published-in-nejm-302487770.html

CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean ... The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12286864/

CagriSema drives weight loss in rats by reducing energy ... Quantifying CagriSema's action on energy intake and expenditure in rats we observe 12% weight loss with a 39% reduction in food intake. By ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642503/

Efficacy and Safety of Cagrilintide Alone and in ... Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.

7. prnewswire.com prnewswire.com/news-releases/novo-nordisks-cagrisema-was-associated-with-significant-reduction-in-blood-pressure-and-showed-anti-inflammatory-effects-while-reducing-the-proportion-of-patients-at-risk-of-developing-heart-disease-over-time-in-new-analyses-at-o-302607596.html

Novo Nordisk's CagriSema was associated with significant ... The reduction with CagriSema (–68.9%) was greater than with semaglutide 2.4 mg alone (–55.4%) or placebo (–16.0%). ... In a mediation analysis, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05567796

NCT05567796 | A Research Study to See How Well ... The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a dummy medicine and 2 other medicines.