2001 Participants NeededMy employer runs this trial

Orforglipron for Obesity

(ATTAIN-NOW Trial)

Recruiting at 183 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 the effectiveness and safety of a new treatment called orforglipron for individuals who are overweight. Researchers aim to determine if this treatment can reduce the risk of obesity-related health issues, such as type 2 diabetes and high blood pressure. The study includes three groups: one taking orforglipron, one starting with orforglipron and switching to a placebo (inactive substance), and one starting with a placebo and switching to orforglipron. Participants should have a waist-to-height ratio of at least 0.5, have unsuccessfully attempted weight loss through diet and exercise, and have a BMI between 25 and 29.9, along with one obesity-related complication like prediabetes or prehypertension. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

Research has shown that orforglipron, a pill acting as a GLP-1 receptor agonist, demonstrates promising safety results in humans. Earlier studies found it to be as safe as, or even safer than, insulin. However, some side effects have been reported. About 90% of people taking the drug experienced side effects, mostly similar to those seen with other drugs in this group, typically including stomach issues like nausea or diarrhea.

A small number of participants (around 10-17%) stopped taking the medication due to these side effects, depending on the dose. It's important to note that these side effects are common for medications like this, and the rates are similar to those seen with other GLP-1 treatments. While the data is encouraging, researchers continue to gather information on long-term safety.12345

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

Orforglipron is unique because it's an oral medication targeting obesity, which could offer a more convenient alternative to current injectable treatments like semaglutide. Unlike other obesity treatments that focus on appetite suppression or fat absorption, Orforglipron works by mimicking a hormone that helps control blood sugar and appetite, potentially leading to significant weight loss. Researchers are excited because this new delivery method could make it easier for patients to manage their condition, improving adherence and outcomes.

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

Research has shown that orforglipron can help people with obesity lose weight. In one study, participants taking a high dose lost about 12.4% of their body weight over 72 weeks, while those on a placebo lost only 2.1%. Another study found that a 6-milligram dose led to an average weight loss of 16 pounds. Orforglipron also helped control blood sugar levels, potentially preventing type 2 diabetes. Some participants experienced side effects like nausea, which is common with this type of treatment. Overall, evidence suggests that orforglipron can aid in weight loss and reduce obesity-related health risks.678910

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults who are overweight and at risk of developing obesity-related health problems like high blood pressure, prediabetes, or abnormal cholesterol. People with certain medical conditions or on specific medications may not be able to join.

Inclusion Criteria

I have at least one health issue related to being overweight, like prediabetes or high blood pressure.
Have an increased waist-to-height ratio of ≥0.5
Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
See 1 more

Exclusion Criteria

I have diabetes of any type.
I have high blood pressure or a history of it.
I have high cholesterol or a history of high cholesterol.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally to evaluate efficacy and safety

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Orforglipron

Trial Overview

The study compares a new medication called Orforglipron to a placebo (inactive pill) to see if it can help prevent obesity-related complications and stop progression to class 1 obesity. Participants are randomly assigned to either group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Placebo to OrforglipronExperimental Treatment2 Interventions
Group II: Orforglipron to PlaceboExperimental Treatment2 Interventions
Group III: OrforglipronExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

New weight loss pill outperforms oral semaglutide for ...

Wise Orforglipron, leads to greater glycaemic control and weight loss for patients with type 2 diabetes than oral semaglutide

Eli Lilly's Orforglipron shows potential for weight loss and ...

average 199-pound participant lost 9.7 pounds. The weight loss increased to 12.2 pounds for those taking 6-milligram doses and 16 pounds for ...

Eli Lilly Glp 1 Pill Data: A Comprehensive Review ...

Weight Reduction Percentages: In high-dose cohorts, significant reductions in body weight were observed, with some participants approaching ...

Orforglipron Challenges Semaglutide in ACHIEVE-3 Trial

The results for orforglipron are striking, with greater A1C reductions and weight loss. We're seeing higher rates of nausea and discontinuation ...

New Phase 3 data (ATTAIN-MAINTAIN) show that orforglipron, ...

In trials, the highest dose averaged 12.4% body weight loss at 72 weeks vs. 2.1% with placebo For patients who plateaued on injectable GLP ...

Very reassuring data revealed (not published, so take with ...

the daily pill #orforglipron was as safe as, or safer than, insulin. It obviously led to greater weight loss and better blood sugar control. ...

Oral GLP-1: Understanding Orforglipron Access and Eligibility

BLUF: Orforglipron is an investigational oral GLP-1 receptor agonist primarily for adults with obesity or overweight plus comorbidities.

Did you hear about orforglipron, the new GLP-1 pill in ...

The trial found that daily use can lead to maintaining weight loss up to a year. : the medication has caused a drastic reduced appetite, raised ...

the first oral, non-peptide GLP-1 receptor agonist ...

early weight-loss data showed reductions of up to ~15% body weight. more side effects and less long-term safety data so far. tide # ...

Orforglipron oral GLP-1: separating hype from trial data

Phase 2 data showed approximately 14.7% weight loss at 36 weeks at the 45 mg dose, with GI side effects consistent with the drug class.