TERN-601 for Obesity

(FALCON Trial)

No longer recruiting at 19 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Terns, Inc.

Disqualifiers: Diabetes, Endocrinologic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called TERN-601 to determine its effectiveness for individuals with obesity or who are overweight. Researchers aim to assess whether TERN-601 is safe, effective, and well-tolerated. Participants will receive varying doses of TERN-601 or a placebo (a harmless pill resembling the treatment) to compare outcomes. This trial suits adults with a body mass index (BMI) of 30 or higher, or a BMI between 27 and 30 with a weight-related health issue, who have maintained a stable weight for at least three months. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant obesity research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that TERN-601 is likely to be safe for humans?

Research has shown that TERN-601, a treatment tested for weight loss, has produced mixed safety results. In earlier studies, TERN-601 led to up to 4.6% more weight loss compared to a placebo. However, some side effects occurred. Specifically, in the group with the most weight loss, 64.7% of participants experienced nausea, and 38.2% experienced vomiting. Additionally, about 12% of participants discontinued the treatment due to these side effects. Thus, while TERN-601 can aid in weight loss, it might cause discomfort for some users. ^{1 2 3 4 5}

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

Researchers are excited about TERN-601 for obesity because it offers a new approach to weight management. Unlike typical treatments like lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide, TERN-601 is taken orally and has multiple dosing options, potentially allowing for personalized treatment plans. This investigational treatment could provide a more convenient and flexible option for patients struggling with obesity, and its novel mechanism of action might target obesity in a way that current treatments do not.

What evidence suggests that TERN-601 might be an effective treatment for obesity?

Research has shown that TERN-601 can aid in weight loss. In studies, participants lost up to 4.6% of their body weight compared to those who took a placebo, a pill with no active medicine. However, about 12% of participants discontinued TERN-601 due to side effects. Although TERN-601 assisted with weight loss, other treatments have proven more effective in similar studies. Despite being safe and easy to use, TERN-601's weight loss results were less impressive than some other options. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults with overweight or obesity are eligible for this trial. Specific health conditions and other criteria will be assessed to determine eligibility, but these details are not provided in the summary.

Inclusion Criteria

My BMI is between 27 and <50, with a weight-related health issue if it's 27-<30.

HbA1c < 6.5%

Stable self-reported body weight for at least 3 months prior to study (< 5% body weight gain or loss)

Exclusion Criteria

My obesity is caused by medication or a hormone disorder.

Lifetime history of suicide attempt

Have diabetes mellitus

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TERN-601 or placebo orally once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TERN-601

Trial Overview The study is testing TERN-601, an oral medication, against a placebo (a pill without active ingredients) to see if it's effective and safe for treating adults with overweight or obesity.

How Is the Trial Designed?

Group I: TERN-601 Dose 4 Experimental Treatment 1 Intervention

Orally administered once daily.

Group II: TERN-601 Dose 3 Experimental Treatment 1 Intervention

Orally administered once daily.

Group III: TERN-601 Dose 2 Experimental Treatment 1 Intervention

Orally administered once daily.

Group IV: TERN-601 Dose 1 Experimental Treatment 1 Intervention

Orally administered once daily.

Group V: Matching Placebo Placebo Group 1 Intervention

Orally administered once daily.

Who Is Running the Clinical Trial?

Terns, Inc.

Lead Sponsor

Trials

5

Recruited

570+

Published Research Related to This Trial

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

A total of 4941 adverse event (AE) reports were identified for antiobesity medicines in Europe from 2007 to 2014, with over 90% classified as serious, including 159 deaths, highlighting significant safety concerns associated with these medications.

The most commonly reported serious AEs were cardiac (19%) and psychiatric disorders (18%), particularly linked to orlistat and rimonabant, indicating a need for ongoing safety monitoring despite the withdrawal of some products from the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. Aagaard, L., Hallgreen, CE., Hansen, EH.[2018]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Current antiobesity drugs in Phase II clinical trials show promise, but many have faced challenges with safety and efficacy, highlighting the need for better options.

Future weight loss treatments may focus on personalized approaches for specific groups and could involve fixed-dose combinations targeting multiple pathways to achieve significant and sustainable weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational drugs in Phase II clinical trials for the treatment of obesity: implications for future development of novel therapies. Jackson, VM., Price, DA., Carpino, PA.[2014]

Three FDA-approved medications for long-term obesity treatment—sibutramine, orlistat, and rimonabant—have shown significant weight loss benefits in large clinical trials lasting 2 to 4 years, with average weight loss of 8%-10% compared to 4%-6% for placebo.

While all medications have side effects, sibutramine can increase blood pressure and heart rate, orlistat can cause gastrointestinal issues like steatorrhea, and rimonabant generally has a favorable safety profile with mild, self-limited nausea and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. Bray, GA., Ryan, DH.[2018]

Citations

1. ir.ternspharma.com ir.ternspharma.com/news-releases/news-release-details/terns-pharmaceuticals-reports-topline-12-week-data-its-phase-2

Terns Pharmaceuticals Reports Topline 12-week Data from ... Results show maximum placebo-adjusted weight loss of 4.6% with 12% treatment discontinuation due to adverse events.

2. ir.ternspharma.com ir.ternspharma.com/news-releases/news-release-details/terns-pharmaceuticals-presents-positive-data-phase-1-study-tern

Terns Pharmaceuticals Presents Positive Data from Phase ... TERN-601's competitive weight loss at 12-weeks, a class leading safety and tolerability profile, and the simplest dose titration amongst GLP-1R agonist ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06854952

NCT06854952 | A Clinical Study to Evaluate the Efficacy, ... A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity (FALCON). ClinicalTrials.gov ID NCT06854952.

4. fiercebiotech.com fiercebiotech.com/biotech/terns-mothballs-obesity-program-after-phase-2-data-fall-short

Terns mothballs obesity program after phase 2 data fall short Across four regimens, the company saw placebo-adjusted weight loss of up to 4.6% at Week 12. Eli Lilly saw deeper weight loss in a phase 2 study ...

5. biospace.com biospace.com/drug-development/terns-turns-away-from-obesity-pill-after-uncompetitive-phase-ii-profile

Terns Turns Away From Obesity Pill After 'Uncompetitive' ... In those who were titrated slowly, for instance, body weight dropped 3.6% at 12 weeks, with effect peaking at 4.6% weight loss in patients given ...

6. reuters.com reuters.com/business/healthcare-pharmaceuticals/terns-pharma-ends-obesity-drug-program-after-mid-stage-trial-data-2025-10-21/

Terns Pharma shelves obesity drug after mid-stage trial ... The once-daily oral drug, TERN-601, which belongs to a class known as GLP-1 receptor agonists, helped patients lose up to 4.6% more weight than ...