Clinical Trials Roundup: New Developments in Obesity, Type 1 Diabetes, and Women’s Health
Medical Doctor | Medical Writer (Preventive & Metabolic Health)
Dr. Jody-Ann McLean holds an MBBCH (Bachelor of Medicine, Bachelor of Surgery) and has a background in clinical medicine and pathology. Her work focuses on evidence-based health content and the interpretation of medical research.
Trial status and details compiled from ClinicalTrials.gov. Results and topline data drawn from sponsor releases or publications, where applicable. Regulatory information drawn from the FDA. Last refresh: 14 September 2026
Over the past couple of weeks, there have been several notable clinical trial developments including a new Phase 3 trial evaluating orforglipron (an oral weight-loss drug) in adults who are overweight but not classified as having obesity, and new results from a Phase 3 trial investigating semaglutide in children with obesity. A Phase 3 type 1 diabetes study has also been terminated for futility. Amid the current knowledge gaps around testosterone use in women, the FDA is also holding a public workshop on testosterone use in menopausal women.
Orforglipron Trial Targets People With Overweight Before Obesity-Related Complications Develop
A Phase 3 trial called ATTAIN-NOW was registered by Eli Lilly at the end of August 2026, and the study is scheduled to begin in September 2026 with primary completion in August 2029. The trial plans to enrol 2001 participants and will investigate an oral GLP-1 medicine called orforglipron (known under the brand name Foundayo) which is a non-peptide drug that was designed to be more resilient in the gastrointestinal tract and has a greater oral bioavailability than some peptide GLP-1 medicines.
Foundayo, in combination with lifestyle changes, is currently FDA-approved for weight management in adults either with obesity or with overweight alongside at least one weight-related comorbid condition. The ATTAIN-NOW trial is an interesting development as instead of looking at a population of adults who already have obesity or obesity-related conditions, it will assess efficacy and safety of orforglipron in those who are overweight with risk factors like prediabetes, prehypertension, or borderline abnormal lipid levels, and investigate any benefit in reducing future risk of obesity-related conditions or developing obesity. This brings into question whether obesity medication can be used as a preventive treatment, and if it can change the trajectory of people at risk.
Trial record: NCT07794579
Semaglutide Trial Reports Results In Children With Obesity
Semaglutide is currently FDA-approved for weight management in adolescents 12 years and over with obesity, and for adults with obesity or overweight alongside at least one weight-related condition. The Phase 3 STEP Young trial specifically looked at children aged 6 to under 12 living with obesity. This is an age group where there are fewer clinically tested and approved treatment options for obesity when lifestyle interventions aren’t enough.
The randomized controlled trial investigated the effect on body weight of once-weekly subcutaneous semaglutide compared with placebo in 165 children with obesity. Lifestyle interventions including a reduced calorie diet and increased physical activity were implemented in both the treatment and the placebo groups.
Novo Nordisk (the trial’s sponsor) released the first results of the trial on the 7th September 2026, stating that the study met its primary endpoint showing a greater BMI reduction in the children within the 6 to under-12 age group treated with semaglutide versus those in the placebo group.
At week 68 of the trial, 40.4% of children who were treated with semaglutide were no longer classified as having obesity in comparison to 0% of the children in the placebo group. This figure is based on the trial product estimand (which estimates the treatment effect if all the children had adhered to treatment). The obesity classification was based on age- and sex-specific BMI percentiles, with the children no longer being classified as having obesity if their BMI fell into either a normal or an overweight category.
The overall safety and tolerability profile of semaglutide was reported to be in keeping with previous Novo Nordisk semaglutide or liraglutide trials and, importantly for children, no safety concerns related to growth or pubertal development were identified. Detailed safety data have not been released yet.
Detailed STEP Young results will be presented later this year at the annual ObesityWeek 2026 from 14-17 November in Washington, DC.
Trial record: NCT05726227
Type 1 Diabetes Trial Terminated for Futility
A phase 3 study called DIAGNODE-3, which was sponsored by Diamyd Medical, aimed to investigate the effectiveness and safety of an investigational immunotherapy drug called Diamyd (also called retogatein). The trial was designed to assess whether this medicine given alongside vitamin D to people with a specific genetic subtype of type 1 diabetes, could preserve the body’s own insulin production through the pancreatic beta cells, or improve blood sugar control.
After the trial’s interim results were analyzed, there was no clinically meaningful effect on a marker for the body’s insulin secretion, and the pre-specified criteria for continuing the trial were not met. At this point (in April 2026) Diamyd Medical made the decision to discontinue the trial, and the ClinicalTrials.gov record was updated on 26th August 2026 to reflect the trial’s termination.
To date, there is still no approved treatment that can stop or reverse the autoimmune destruction of the insulin-producing pancreatic beta cells that happens in established type 1 diabetes, although newer treatments like teplizumab can delay the onset of type 1 diabetes or the loss of insulin production in certain cases.
Trial record: NCT05018585
FDA To Examine Testosterone Use In Menopausal Women
Testosterone is being widely spoken about for both its use in women and the knowledge and research gaps around it. There is currently no FDA-approved testosterone product for women, and the only current evidence-based indication is for hypoactive sexual desire disorder (HSDD).
Despite this, the FDA describes there being a growing off-label use of testosterone therapy in menopausal women, and notes the lack of research in areas like sexual health, cognition, mood and musculoskeletal health. There is also not enough long-term safety data or information on how to measure or interpret testosterone levels.
The FDA is holding a public workshop on the 17th September 2026 to explore these questions surrounding testosterone for menopausal women. The intent of the workshop is to explore the current evidence and identify where and what knowledge gaps there are so that this can be directed towards future research and drug development.
The workshop will be held both in-person and virtually, with virtual registration still being open. A docket is open for public comments on the risks and benefits of testosterone use in women, which closes on October 19th 2026.
Disclaimer: This content is for informational and educational purposes only. It is not intended to provide medical advice or to take the place of such advice or treatment from a personal physician. Consult a qualified healthcare professional regarding specific health questions.