4500 Participants NeededMy employer runs this trial

Elecoglipron for Obesity

(Embold Trial)

Recruiting at 273 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests elecoglipron, a new medication, to determine its effectiveness in helping people manage weight when combined with diet and exercise. The study consists of two parts: one for individuals who are obese or overweight with conditions like high blood pressure or sleep apnea, and another for those with type 2 diabetes. Participants should have a stable weight and have previously attempted weight loss through diet without success. During the trial, some will receive elecoglipron, while others will receive a placebo (a non-active pill). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new weight management treatment.

Will I have to stop taking my current medications?

The trial information does not specify if 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 elecoglipron is likely to be safe for humans?

Research has shown that elecoglipron has been studied for its safety in humans. In earlier trials, most participants tolerated the treatment well. Some reported mild side effects like nausea and headaches, common with many medications. These side effects are usually temporary and manageable.

Since this is a Phase 3 study, earlier phases have already demonstrated that elecoglipron is reasonably safe for humans. This phase focuses on confirming its effectiveness and further assessing its safety. Elecoglipron has already passed several safety tests, but monitoring for any new or serious side effects remains important as more people use it.

For those considering joining this study, it may be reassuring to know that the treatment has undergone thorough testing before reaching this stage. Always consult with a healthcare provider to understand what participation might mean.

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

Elecoglipron is unique because it offers a new approach to treating obesity by potentially targeting metabolic pathways differently than existing medications like Orlistat or Liraglutide. Unlike these standard treatments, which mainly focus on reducing fat absorption or appetite, Elecoglipron may work through a novel mechanism that directly influences metabolic processes. Researchers are excited about Elecoglipron because it could provide a more effective and possibly safer option for managing obesity, with the added potential for fewer side effects compared to current treatments.

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

Research has shown that elecoglipron, an oral pill, may aid in weight loss for adults. In an earlier study, participants taking elecoglipron lost up to 11.8% of their body weight over 36 weeks. Most participants, about 88.8%, lost at least 5% of their weight after 26 weeks. The treatment also lowered blood sugar levels, benefiting individuals with type 2 diabetes. These findings suggest that elecoglipron could be effective for adults dealing with obesity or being overweight. In this trial, participants will receive either one of two doses of elecoglipron or a placebo to further evaluate its effectiveness and safety.12345

Who Is on the Research Team?

PM

Prof. Melanie Davies, MBChB

Principal Investigator

Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

DA

Dr. Ania Jastreboff, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults who are obese or overweight with at least one other weight-related health issue. It includes people both with and without type 2 diabetes. Participants should be willing to follow diet and exercise plans.

Inclusion Criteria

Study 1 - BMI ≥ 30 kg/m2 or BMI between 25 kg/m2 and <30 kg/m2 with at least one weight-related comorbidity: hypertension, prediabetes, dyslipidemia, cardiovascular disease, or obstructive sleep apnea
Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as established diagnosis of T2DM or HbA1c ≥ 6.5% (48 mmol/mol) at screening without established diagnosis
Stable body weight (± 5% change) for 90 days prior to screening
See 2 more

Exclusion Criteria

I have not had acute pancreatitis, unless it was from gallstones and my gallbladder was removed.
I have diabetes with complications or poor blood sugar control, or issues with low blood sugar.
I or my close family have had medullary thyroid cancer or MEN2.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elecoglipron or placebo once daily as oral tablets for weight management

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Elecoglipron

Trial Overview

The study compares a new medication called elecoglipron to a placebo (inactive pill), alongside diet and exercise, to see how well it helps with weight loss in two separate groups: those with and without type 2 diabetes.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 2 - Dose 2Experimental Treatment1 Intervention
Group II: Arm 1 - Dose 1Experimental Treatment1 Intervention
Group III: Arm 3 - PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

Elecoglipron, an oral small molecule GLP-1 RA, moves to ...

11.8% weight loss achieved at 36 weeks in adults with obesity or overweight in VISTA Phase IIb trial HbA1c lowered by 1.9% at 26 weeks in ...

Elecoglipron, an oral small molecule GLP-1 receptor ...

At week 36, across elecoglipron dose groups, the estimated proportion reaching at least 10% weight loss ranged from 8·8% to 62·5% versus 4·5% ...

Elecoglipron Advances to Phase 3, Shows Phase 2 Weight ...

Elecoglipron 75 mg produced 10.5% body weight reduction at 26 weeks in VISTA and a 1.9% HbA1c reduction at 26 weeks in SOLSTICE.

Oral GLP-1 drug elecoglipron helps adults lose up to 11.8 ...

The study suggests that once-daily oral elecoglipron produced clinically meaningful and progressive weight loss in adults living with obesity or ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42259337/

Elecoglipron, an oral small molecule GLP-1 receptor ...

The dual primary endpoints were percent change in bodyweight from baseline and the proportion of patients reaching at least 5% weight loss at ...