Orforglipron for Obesity
(ATTAIN-OA PAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the efficacy and safety of orforglipron, a new potential drug, for individuals who are overweight or have obesity and suffer from knee osteoarthritis with pain. Participants will receive either orforglipron or a placebo to compare outcomes. The study seeks individuals with a BMI of 27 or higher, who have unsuccessfully attempted weight loss through diet, and experience knee osteoarthritis symptoms such as morning stiffness or a grinding sensation in the knee. The trial will last approximately 74 weeks. 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 treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used any GLP-1 receptor agonist medication within 180 days before screening.
Is there any evidence suggesting that orforglipron is likely to be safe for humans?
Research has shown that orforglipron appears safe for people with obesity. Earlier studies explored its use for weight loss and found it well-tolerated. Participants lost weight, indicating the treatment's effectiveness, and no major safety issues were reported.
Regarding side effects, data from previous trials do not reveal any significant safety concerns. This is encouraging, especially since the treatment is now in a later stage of testing, which usually indicates it has proven safe in earlier studies. Additionally, orforglipron is being tested for other conditions, like diabetes, further supporting its safety.12345Why do researchers think this study treatment might be promising for obesity?
Orforglipron is unique because it offers a new oral treatment option for obesity, potentially simplifying the regimen compared to current injectable therapies like semaglutide and liraglutide. Unlike these standard treatments, orforglipron targets obesity through a novel mechanism by acting as a non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist. Researchers are excited about orforglipron because it might provide similar or improved weight loss benefits without the need for injections, making it more convenient for patients.
What evidence suggests that orforglipron could be an effective treatment for obesity and knee osteoarthritis?
Research has shown that orforglipron aids in weight loss. In earlier studies, participants taking orforglipron lost between 7.8% and 12.4% of their starting weight over 72 weeks. Another study found that participants lost an average of 16 pounds with the highest dose, with most weight loss coming from fat reduction. In this trial, participants will receive either orforglipron or a placebo. Previous research indicates that orforglipron results in significantly more weight loss compared to a placebo.12678
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for individuals with obesity or overweight who also have knee osteoarthritis and pain. Participants will be involved in the study for approximately 74 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive orforglipron or placebo orally to assess efficacy and safety in treating obesity or overweight with osteoarthritis of the knee
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Orforglipron
Trial Overview
The trial is testing Orforglipron, a new potential treatment, against a placebo to see how well it works and its safety in people with both obesity or overweight and knee osteoarthritis.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive orforglipron orally
Participants will receive orforglipron orally
Participants will receive placebo orally
Participants will receive placebo orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Orforglipron, an Oral Small-Molecule GLP-1 Receptor ...
In the pooled orforglipron groups, 73.1% of the body-weight reduction was due to a loss in fat mass and 26.9% was due to a loss in lean mass.
2.
investor.lilly.com
investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statisticallyLilly's oral GLP-1, orforglipron, demonstrated statistically ...
In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs (7.9%) at the highest dose. Given that ...
Orforglipron, an Oral Small-Molecule GLP-1 Receptor ...
Conclusions: In adults with obesity, 72-week treatment with orforglipron led to significantly greater reductions in body weight than placebo; ...
4.
news.weill.cornell.edu
news.weill.cornell.edu/news/2025/09/oral-glp-1-drug-orforglipron-promotes-substantial-weight-loss-in-clinical-trialOral GLP-1 Drug Orforglipron Promotes Substantial ...
Over 72 weeks, patients in the low-, medium- and high-dose orforglipron groups lost an average of 7.8%, 9.3% and 12.4% of their initial body ...
New GLP-1 drug delivers weight loss in a pill
Orforglipron resulted in significantly greater weight loss than placebo. After 72 weeks, mean weight reduction from baseline was –7.5% (6 mg ...
Safety and efficacy of the new, oral, small-molecule, GLP-1 ...
Preliminary evidence supports that orforglipron and danuglipron are efficient in glycemic control and weight reduction in T2DM, obesity or both.
NCT05869903 | A Study of Orforglipron (LY3502970) in ...
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related ...
Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults ...
This phase 2 trial of orforglipron showed weight reduction ranging from 8.6% to 12.6% at 26 weeks and ranging from 9.4% to 14.7% at 36 weeks.
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